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This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Verification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipmnet, Process, Software, and quality management system validations.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Verification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipmnet, Process, Software, and quality management system validations.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details.jpg "Steven Laurenz - Complinace4All")
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization.
Speaker: Steven Laurenz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.
Speaker: Steven Laurenz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions.
Speaker: Steven Laurenz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
As global trade undergoes profound changes, companies and governments must look beyond today's tariff challenges and prepare for a more complex, uncertain future.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Trade deals and tariff negotiations are key tools governments use to influence economic outcomes, build alliances, and protect domestic industries.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training provides detailed, practical insight into navigating tariff regulations, focusing on legal obligations and the compliance processes that international businesses must follow.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tariffs are more than just taxes on imports-they are instruments of trade policy that influence the behavior of nations, companies, and consumers.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Assessment of the cause for a non-compliance is a structured series of branching questions.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Assessment of the cause for a non-compliance is a structured series of branching questions.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Price: $199.00 | View Details
Assessment of the cause for a non-compliance is a structured series of branching questions.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, we will examine the overall structure of design control as it relates to the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.
Speaker: Dev Strischek | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization's desired credit risk objectives.
Speaker: Dev Strischek | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Learn key assumptions in a projection and how to assess validity, the value of a downside-most likely projection to stress test the assumptions
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
What complicates survival in this current economic environment is the combination of elevated inflation and possible recession
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
One of the most basic analytical and underwriting tools a banker must have is the ability to determine whether a borrower can repay its short-term borrowings based on the financial information available
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In today’s world of evolving technologies and businesses, financial organizations are taking on increasing levels of risk.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Ratio analysis helps lenders and analysts to determine a borrower’s operating performance (profitability and productivity) and financial condition (liquidity, leverage, solvency) by rendering the financial statements into ratios.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Several new principles warrant review to understand how they will affect both borrowers and lenders-new GAAP for revenue recognition, lease capitalization, current expected credit losses (CECL) as well as changes to not-for-profit financials.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The regulatory agencies and investors expect bank and other organizations extending credit to possess a strong credit culture. This session will explain what a credit culture is, how to implement it, and how to maintain a strong credit culture.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Both lenders and borrowers like to to use EBITDA as proof of repayment ability, but as noted earlier, it overestimates repayment ability.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Lenders, accountants, and suppliers are in an excellent position to use their knowledge to serve as effective financial advisors to their borrowers.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This session explains how to participants can improve their ability to resolve a problem or issue by breaking down its components, evaluating alternative solutions, selecting the most logical and cost-effective option and implementing it.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mapping and evaluating all the steps in a pharmaceutical warehousing and distribution workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mapping and evaluating all the steps in a pharmaceutical manufacturing and packaging workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The MENA region suffers from a Drug & Device Lag, meaning innovative products typically do not reach the market for 10+ years, after they are approved and launched in the U.S. or EU. Because of this, there exists significant opportunity for U.S. and EU developed products, if the regulatory hurdles can be navigated
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mastering Power-User techniques in Microsoft Word is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A customized practical PowerPoint example is provided with slides in sequence for each question posed to DeepSeek for demonstration and “hands-on” practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A customized practical Excel example is provided with slides in sequence for each question posed to DeepSeek for demonstration and “hands-on” practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A customized practical Excel example is provided with slides in sequence for each question posed to DeepSeek for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A customized practical Excel example is provided with slides in sequence for each question posed to DeepSeek for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mastering AI is now a fundamental and highly marketable skill set in Excel and is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A customized practical PowerPoint example is provided with slides in sequence for each question posed to ChatGPT for demonstration and “hands-on” practice by attendees
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In today's world, there are a ton of data to manage. Data is coming from many different sources.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Post-Market Surveillance (PMS) and Vigilance Reporting for Medical Devices and Combination Products are critical components of regulatory compliance, ensuring ongoing patient safety and product effectiveness after market approval.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This 60-minute webinar on GMP Compliance for Biopharmaceuticals and Cell & Gene Therapy Products provides a comprehensive overview of regulatory expectations, quality management principles, and industry best practices for ensuring compliance in these highly specialized fields.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
A risk-based approach to supplier qualification in GMP manufacturing ensures that suppliers are evaluated, selected, and monitored based on their potential impact on product quality and patient safety.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Good Documentation Practices (GDP) are a critical requirement in both Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) environments, ensuring the accuracy, integrity, and reliability of records that support regulatory compliance.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continue to evolve, posing ongoing challenges for medical device and diagnostic manufacturers. With 2025 bringing critical deadlines, regulatory updates, and new compliance expectations, companies must stay ahead to ensure smooth market access and adherence to stringent requirements.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The FDA’s transition from the Quality System Regulation (QSR) to ISO 13485 marks a significant shift in medical device regulatory compliance, aligning U.S. quality management requirements with global standards.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Life sciences projects are highly complex, requiring a strategic approach to managing regulatory compliance, cross-functional teams, budgets, and timelines.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Effective budgeting and resource allocation are critical to the success of clinical trials, ensuring financial sustainability while maintaining compliance and efficiency.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Managing global teams in the life sciences sector requires a strategic approach to leadership, communication, and regulatory alignment.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Regulatory submissions for drug development require precise project scheduling to meet critical milestones and ensure timely market entry.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Medical device submissions in the US and EU require precise project scheduling to ensure timely regulatory approvals.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Effective risk management is essential for ensuring the success of life science projects, where regulatory compliance, operational efficiency, and financial sustainability are critical.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Effective collaboration between diverse corporate functions is critical for success in Research & Development (R&D).
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Effective Standard Operating Procedure (SOP) writing and management are critical for ensuring regulatory compliance and operational consistency.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
A compliant training program is essential for ensuring personnel in GMP, GCP, and quality system-regulated environments are knowledgeable, competent, and audit-ready.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This 60-minute webinar provides a comprehensive guide on how to effectively prepare for regulatory inspections conducted by the FDA, EMA, and Notified Bodies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Effective technical writing is critical for successful regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Premarket Approval (PMA) submissions.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar explores the power of Hybrid Project Management, combining the structured, predictable approach of traditional Waterfall methodologies with the flexibility and adaptability of Agile practices.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This 60-minute webinar explores the key differences between Agile and Traditional (Waterfall) Project Management in the life sciences industry, helping professionals determine the best approach for their specific projects
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This 60-minute webinar on Clinical Trial Risk Management will provide a comprehensive overview of the evolving regulatory landscape under ICH E6(R3) and FDA expectations for risk-based quality management (RBQM).
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar, Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping, provides a comprehensive understanding of regulatory requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar, Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements, provides a comprehensive overview of data integrity principles, regulatory expectations, and compliance strategies in pharmaceutical and clinical environments.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ensuring that personnel are properly trained is critical for maintaining compliance with Quality System Regulations (QSR) and ISO standards in regulated industries such as medical devices and pharmaceuticals.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention."
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must do it because the regulation requires it.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and fixed
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Pharmaceutical manufacturing sites continuously compete within the same company to maintain production volumes and avoid closures.To attain the status of a high-performing organization, manufacturing sites are implementing strategies and practices like operational excellence and performance reliability.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We must be aware of the compliance risks that are relevant with digital assets, specifically, cryptocurrencies.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It’s about time we leverage the tools and resources to make us more effective and efficient. I’m talking about ChatGPT. As with any tools, there are pros and cons. We will discuss the background, understanding general concepts, the tools available and what the future may bring.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Data protection and privacy is an important issue this day and age for the public.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Getting Started Building Reports and Dashboards"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables. Whether you're aiming to construct dynamic dashboards, conduct in-depth data analysis, or simply streamline data summaries for personal or business purposes, Pivot Tables are your key to success.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This training is designed to revolutionize the way you work with Excel. Copilot is an AI-powered tool that enhances your Excel experience by automating complex tasks, providing intelligent suggestions, and improving overall efficiency. Whether you're dealing with large datasets, creating intricate formulas, or simply trying to streamline your daily workflow, Copilot is here to help.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Elevate your Excel prowess with this training. Aimed at users already versed in Excel's core functions (SUM, X/VLOOKUP, COUNTIF etc), this course introduces users to some of the new innovative functions added since 2020, exclusively available to Microsoft 365, Excel 2021 and Excel 2024 users.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In today’s fast-paced and data-driven world, efficiency, accuracy, and innovation are more critical than ever. This session will introduce you to the seamless integration of ChatGPT with Excel, showing how AI can dramatically boost your spreadsheet capabilities.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Getting Started Building Reports and Dashboards"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables. Whether you're aiming to construct dynamic dashboards, conduct in-depth data analysis, or simply streamline data summaries for personal or business purposes, Pivot Tables are your key to success.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use DEEPSEEK for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of DEEPSEEK for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use DEEPSEEK for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of DEEPSEEK for Excel, like basic navigation and data import/export
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A customised practical Excel Worksheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This easy to follow demonstration clearly explains how to effectively post ChatGPT questions on more advanced Excel topics and extract more accurate responses.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mastering AI is now a fundamental and highly marketable skill set in Excel and is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This easy to follow demonstration clearly explains how to effectively post ChatGPT questions on more advanced Excel topics and extract more accurate responses.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mastering AI is now a fundamental and highly marketable skill set in Excel and is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about. Also, how FDCPA relates to all levels of staff. We will also discuss the current regulatory & economic environment to help us determine what 2024 could look like.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The integration of artificial intelligence (AI) into project management is transforming the way projects are planned, executed, and monitored.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 90-minute webinar will begin with an introduction to the fundamentals of project management, tailored specifically for those who may not have formal training in the field.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Data protection and privacy is an important issue this day and age for the public.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Since Compliance Officers have direct contact with all parts of the business, it's essential that they have the necessary tools to succeed and help shift the compliance culture of an organization.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The topic delves into the critical interplay between human factors, design processes, and patient safety within the realm of healthcare technology. It begins by elucidating the multifaceted nature of human errors, encompassing cognitive, perceptual, and physical aspects, and underscores their potential impact on patient well-being.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 90-minute webinar will delve into the fundamental aspects of HFE, emphasizing its pivotal role in enhancing safety, efficiency, and overall user experience within the medical device landscape.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In today's data-driven world, having a strong command of Excel is essential, and understanding the Data Analysis Expressions (DAX) formula language is the key to unlocking the true potential of Excel's Power Pivot and Data Model features.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use ChatGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities by applying a sound, project management approach. Each validation effort includes a vast set of activities and tasks required to get the job done. These can be managed more effectively by better understanding how to apply a project management approach to them all, regardless of size.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We will explore the best practices and strategic approach for evaluating Excel spreadsheets used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The purpose of this workshop is to use the features of the data ribbon and the PivotTable of Excel for what we call datamining.
Speaker: Isaac Gottlieb | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control. We will discuss how to determine the level of impact assessment needed for what type of changes and how to base this decision on risk.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.
Speaker: Alan M Golden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This workshop is about understanding what is behind the Monte Carlo Simulation.
Speaker: Isaac Gottlieb | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 90-minute webinar is designed to provide professionals across various industries with a comprehensive understanding of the critical intersection between effective technical writing, regulatory compliance, and copyright considerations.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A customised practical Excel Worksheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In today's world, there are a ton of data to manage. Data is coming from many different sources.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
Speaker: Michael Esposito | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industrial systems worldwide.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Unlock the full potential of Excel with our deep-dive webinar into the newly introduced GROUPBY and PIVOTBY functions.
Speaker: Abdelrahman Abdou | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dive deeper into Excel Pivot Tables with our upcoming webinar, designed for those who are already familiar with the basics and ready to explore more sophisticated functionalities.
Speaker: Abdelrahman Abdou | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This comprehensive three-hour virtual seminar, titled "Mastering AI Integration in Project Management: Leveraging ChatGPT for Enhanced Efficiency and Compliance in FDA-Regulated Industries," is designed to provide project management professionals with a thorough understanding of the practical applications of AI tools like ChatGPT.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This 90-minute webinar is designed to provide project management professionals with comprehensive insights into the practical applications of AI tools like ChatGPT.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The integration of artificial intelligence (AI) into project management is transforming the way projects are planned, executed, and monitored.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is not possible to present a complete treatment of project management in the span of 4-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 90-minute webinar will begin with an introduction to the fundamentals of project management, tailored specifically for those who may not have formal training in the field.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizens’ personal data when they reside in the European Union (EU).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Speaker: Charles H. Paul | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Speaker: Charles H. Paul | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar is broken into two phases. Phase one will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The course provides a concise overview of how accountants can use ChatGPT to assist with communications involving intricate and often sensitive topics that require a deep understanding of both financial principles and human resource policies. These conversations can range from budgeting and compensation to ethical considerations and regulatory compliance.
Speaker: Garrett Wasny | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
Speaker: Charles H. Paul | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
This seminar is broken into two phases. Phase One corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course offers an in-depth look into Generative AI and its transformative impact on the accounting profession. At the core of Generative AI are technologies that can literally "see, speak, hear, write, and create" in multimodal contexts.
Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In today's data-driven landscape, the fusion of Excel's computational might with ChatGPT's intelligent querying transforms ordinary accounting tasks into dynamic, insightful financial analyses. This specialized masterclass unveils the power behind integrating Excel and ChatGPT, aimed at accountants, financial analysts, and business professionals eager to unlock new levels of efficiency and creativity in their financial workflows.
Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives. This course provides guidance on how to implement and maintain the desired level of credit risk management with practical tools and techniques.
Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 90-minute webinar will delve into the fundamental aspects of HFE, emphasizing its pivotal role in enhancing safety, efficiency, and overall user experience within the medical device landscape.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about. Also, how FDCPA relates to all levels of staff. We will also discuss the current regulatory & economic environment to help us determine what 2024 could look like.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course is designed to teach learners how to use CHATGPT and other AI tools for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
With AI, we need to understand the risks and opportunities it presents. The risk can be high, but prevention is the key. With every technology, there can be element of good and evil. Within financial services. AI can be applied to identify unusual activity, show inconsistent data, remove manual efforts, improve collaboration, and offer a quick and efficient means to review vast amounts of information.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
“From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA” is a comprehensive training session designed to provide participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating dietary supplements.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course offers an in-depth look into Generative AI and its transformative impact on the accounting profession. At the core of Generative AI are technologies that can literally "see, speak, hear, write, and create" in multimodal contexts.
Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The course provides a concise overview of how accounting professionals can leverage ChatGPT, OpenAI's powerful language model, to innovate and enhance their business advisory services. In plain language the presentation integrates theory and practice, and demonstrates how various enterprise evaluation methodologies can be applied in combination with ChatGPT to sharpen your business analysis and increase your organization’s efficiency, profitability, and growth
Speaker: Garrett Wasny | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In today's data-driven landscape, the fusion of Excel's computational might with ChatGPT's intelligent querying transforms ordinary accounting tasks into dynamic, insightful financial analyses. This specialized masterclass unveils the power behind integrating Excel and ChatGPT, aimed at accountants, financial analysts, and business professionals eager to unlock new levels of efficiency and creativity in their financial workflows.
Speaker: Garrett Wasny | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The course provides a concise overview of how accountants can use ChatGPT to assist with communications involving intricate and often sensitive topics that require a deep understanding of both financial principles and human resource policies. These conversations can range from budgeting and compensation to ethical considerations and regulatory compliance.
Speaker: Garrett Wasny | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Ultimately costing principles, such as the causality principle, must be converted into practical practices with supporting tools.
Speaker: Gary Cokins | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about. Also, how FDCPA relates to all levels of staff. We will also discuss the current regulatory & economic environment to help us determine what 2024 could look like.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
As an introduction we point out how important sustainability is for the planet as a whole and how companies will be faced with increasing demands on their impact on society, in all aspects of the term. We also give a brief overview of how sustainability has been wrongly tackled in the past.
Speaker: Willy Vandenbrande | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details.jpg "Dr. Kimberly N. West - Complinace4All")
In today's digital world, artificial intelligence (AI) is making waves in education. But with all the talk of AI-powered this and AI-powered that, you might be wondering, "What does that even mean for me as a teacher?"
Speaker: Dr. Kimberly N. West | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
AI for Project Managers: Boost Your Skills and Supercharge Your Projects
Speaker: Dr. Kimberly N. West | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mastering AI Governance: Leading the Way Responsibly
Speaker: Dr. Kimberly N. West | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
In this webinar, we take an in-depth exploration of how AI, particularly ChatGPT, can revolutionize Excel usage and go beyond traditional spreadsheet functionalities. Attendees will gain valuable insights into the following key topics:
Speaker: Alan Murray | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant. You are half listening to the presentation while thinking about some of the other work you need to complete on different matters. The installation will take a year to execute and will require the coordination with several functions inside and outside of the company.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
People and communications skills are very important in dealing with customers, but have little connection to doing good lab work. This webinar points out some approaches and skills to connect the two areas.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This webinar will discuss what the new QMSR will require. A key element is the incorporation of ISO 13485 into the new 820 by reference. Major emphasis will be upon risk management in accordance with ISO 14971 (-:2019), which currently has only casual reference in 820.30. The FDA views risk management as an “essential systematic practice” to ensure that devices are safe and effective. If the proposed rule is finalized, it will enhance some parts of ISO 13485. Device manufacturers will need to enhance risk management procedures for specific devices and in all other areas of their businesses to align with the QMSR. Design Control (ISO 13485 7.3 Design and Development) will have limited application to Class I devices, but fully involve Class II and III (US classifications) as is currently done in the US but not the EU.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The feeling is sometimes created that technology itself leads the waves of change.
Speaker: Willy Vandenbrande | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals”
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Your data is only as good as the information you can derive from it. Power Pivot enables you to gain better business insights and make more informed business decisions.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables. Whether you're aiming to construct dynamic dashboards, conduct in-depth data analysis, or simply streamline data summaries for personal or business purposes, Pivot Tables are your key to success.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Become an Excel Hero in your organization! Make yourself indispensable. If these are your goals, having a good understanding of Excel's Logic functions is critical. It will help you with scenarios like these:
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Elevate your Excel prowess with this training. Aimed at users already versed in Excel's core functions (SUM, X/VLOOKUP, COUNTIF etc), this course introduces users to some of the new innovative functions added since 2020, exclusively available to Microsoft 365 and Excel 2021 users
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
During this webinar we will provide information on the backgrounds of FDA employees, how FDA employees are trained, how they interact with the regulated industry.
Speaker: Larry Stevens | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Going “beyond the basics” Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Plan and initiate your projects with confidence, knowledge and consistency.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Understand and apply the power of linking techniques within Excel and other key MS Office applications to boost productivity and efficiency for you and your organization.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
PivotTables are reputed to be the most powerful “in-built” feature in Excel aside from Macros.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.
Speaker: Meredith Crabtree | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
China's Life Sciences Compliance webinar will discuss the regulatory structure and requirements for compliance against China's NMPA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device.
Speaker: Robert J. Russell | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Revolutionize the way you communicate data with this cutting-edge training on Excel visual storytelling. Discover the power of visual data representation to transform complex numerical information into compelling, insightful visual narratives
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Impress your boss. Impress your colleagues. Turn drab into fab. Tell your story with awesome charts in Excel. This webinar will equip you with the knowledge you need to turn your numerical data into a set of engaging, attention-grabbing and easy-to-understand visuals!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In today's world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel is an essential tool for anyone who works with data, from entry-level employees to seasoned professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Since Compliance Officers have direct contact with all parts of the business, it’s essential that they have the necessary tools to succeed and help shift the compliance culture of an organization. This webinar is geared towards Compliance Officers in an organization that deal with internal stakeholders. We will discuss ways to train compliances officers effectively and how to go about it.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Since Compliance Officers have direct contact with all parts of the business, it’s essential that they have the necessary tools to succeed and help shift the compliance culture of an organization.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
During this webinar, we go through each step and discuss best practices to create and implement a successful compliance training program
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This session describes how to solve costly business problems and add real value to organizations by applying the best of Lean Six Sigma with enhanced score-carding within an Operational Excellence system.
Speaker: Forrest Breyfogle | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Effective Key Performance Indicator (KPI) metric management in an organization is critical; however, there are issues with traditional metric reporting and its accompanying goal-setting practices.
Speaker: Forrest Breyfogle | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Scientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation is a dynamic and comprehensive 90-minute webinar designed to empower researchers, students, and professionals in the life sciences field with essential skills for effective written communication.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 90-minute webinar is designed to provide professionals across various industries with a comprehensive understanding of the critical intersection between effective technical writing, regulatory compliance, and copyright considerations.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 90-minute webinar delves into the critical intersection of post-market surveillance and project management, providing professionals across industries with comprehensive insights into ensuring long-term success.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The webinar on offers a comprehensive exploration of the pivotal strategies aimed at minimizing errors in one of the most critical sectors of the pharmaceutical industry. The introductory segment sets the stage by emphasizing the paramount importance of error reduction in drug manufacturing for ensuring product safety, efficacy, and regulatory compliance.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Many virtual companies incorrectly think they don't need SOPs or GMP training.
Speaker: Arvilla Trag | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We will cover the changes and impact on validation as a result. We will also cover FDA’s recent draft guidance on Computer Software Assurance (CSA) and what that means in terms of how to approach validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
During the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
To gain a practical “hands-on” understanding of how to efficiently create, manage and run Macros in Excel.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The ability to analyze data is a powerful skill that helps make better decisions. Microsoft Excel is one of the top tools for data analysis and PivotTables are arguably the most popular analytic tool.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Tables are a powerful Excel functionality to streamline many data management functions.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Understanding effective and accurate task management, durations, linking and scheduling are essential to start your projects correctly and minimise major adjustments, delays and cost impacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Verification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you work for any firm that manufactures products regulated by FDA, you very likely will experience an FDA inspection.
Speaker: Larry Stevens | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.
Speaker: Justin Muscolino | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
As an introduction we point out how important sustainability is for the planet as a whole and how companies will be faced with increasing demands on their impact on society, in all aspects of the term.
Speaker: Willy Vandenbrande | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will explain the process of analyzing and minimizing cyber risks for premarket submissions. It will explain how cyber risks are identified and mitigated.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Understanding effective and accurate task management, durations, linking and scheduling are essential to start your projects correctly and minimise major adjustments, delays and cost impacts.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The ability to analyze data is a powerful skill that helps make better decisions. Microsoft Excel is one of the top tools for data analysis and PivotTables are arguably the most popular analytic tool.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Engaging and professional new features help you dazzle your audience with a wide range of captivating options.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training, and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Business continuity planning is crucial for contract manufacturers operating in the life sciences industry
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In today's fast-paced operational environments, organizations face challenges related to human performance, human error, and mental load. This comprehensive two-hour training program aims to equip participants with the knowledge, skills, and strategies to reduce performance failures in operations.
Speaker: Charles H. Paul | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Tables are a powerful Excel functionality to streamline many data management functions.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human Error Reduction Techniques for Floor Supervisors
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The webinar begins with an introduction to the regulatory landscape governing contract manufacturing operations. The presenter, an industry expert with extensive knowledge of FDA and European regulatory guidelines, sets the stage by highlighting the importance of compliance and its impact on product quality, patient safety, and market access.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 3-Hour seminar covers the details of the Regulatory Requirements for a wide range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices, and Combination Products.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $149.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Clinical trial project management is a complex and dynamic process that requires careful planning, coordination, and communication among stakeholders.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Project management plays a critical role in ensuring quality planning and management throughout the product lifecycle. The project manager is responsible for creating a comprehensive quality management plan, implementing quality control procedures, and identifying areas for continuous improvement. By doing so, they ensure that the final product meets the quality objectives and customer requirements.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel’s 500+ functions represent a potent set of power tools that simplifies many different kinds of formulas and gives you a huge number of computational possibilities.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed. The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives. This course provides guidance on how to implement and maintain the desired level of credit risk management with practical tools and techniques.
Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
Speaker: Karl Nobert | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training, and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is not possible to present a complete treatment of project management for this industry in the span of 90 minutes. It is however possible to focus on those most critical project management aspects that are critical to the success of any project within biotechnology and the biomedical industry in general.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though Training is considered the "vaccine for mistakes," Training is as good as its effectiveness.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Due to the growth of the cybersecurity threat to electronic records, computer-controlled manufacturing, and medical devices, the US FDA has issued Guidances for Industry, e.g.: 1) "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Document", and 2) "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and 3) "Postmarket Management of Cybersecurity in Medical Devices" Draft.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
In addition to producing a Trial Master File (TMF), companies engaged in the conduct of human clinical trials must adhere to FDA’s requirements for Computer System Validation (CSV) and Data Integrity. In addition, they must adhere to specific government regulatory requirements. Certain documents, content, and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
Speaker: Carolyn Troiano | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye appeal to your charts with simple formatting techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel’s 500+ functions represent a potent set of power tools that simplifies many different kinds of formulas and give you a huge number of computational possibilities.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Ray Evans | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Clinical trial project management is a complex and dynamic process that requires careful planning, coordination, and communication among stakeholders.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Project management plays a critical role in ensuring quality planning and management throughout the product lifecycle. The project manager is responsible for creating a comprehensive quality management plan, implementing quality control procedures, and identifying areas for continuous improvement. By doing so, they ensure that the final product meets the quality objectives and customer requirements.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Effective project management is essential in the development of In Vitro diagnostics. It ensures the timely completion of the project, and the efficient use of resources, coordination of teams, risk management, and quality management.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is important for a project manager to understand how the project management process integrates into drug development because drug development is a complex and highly regulated process that involves various stages, including discovery, pre-clinical development, clinical development, regulatory submission, and post-marketing surveillance.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Ray Evans | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though Training is considered the "vaccine for mistakes," Training is as good as its effectiveness.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Closed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, on a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is intended for Pet Food Industry Representatives, Manufacturers, Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, Market Watchers, and Investment Analysts seeking an understanding of how pet food is regulated in the United States.
Speaker: Karl Nobert | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Bioassays are used to demonstrate that a biological product performs per the stated function and potency. Typically, these methods are performed in living systems. Cell-based methods can have inherent variability due to the nature of living systems. Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Tables are a powerful Excel functionality to streamline many data management functions.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Skills to effectively manage, present and communicate data are now vital in the competitive financial and business analysis fields and offer vast opportunities to expand accounting client services and career paths.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Emails are a core business communication tool. The speed and volume of email have dramatically changed business communication. The not-so-old standards for professional correspondence have changed and will continue to do so. Employees need to know the best strategies to communicate effectively. An effective business email is easily understood, but it is not so easily written.
Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Good leaders walk the talk, but they also “write right”. They know how to say in a few words what needs to be said in crisp, clear language. The road to bad communication is paved with good intentions but poor construction. Readers know when subjects and verbs don’t agree when punctuation misses the point when words don’t fit, and content is confusing. In this session, learn how a few basic rules on grammar, punctuation, and usage can improve business written communications with clearer, more succinct content.
Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will begin with an explanation of the process and how it originally conflicted with all regulatory bodies worldwide and how it now can be applied, with minor adjustments, to counter those original difficulties. The webinar will also discuss when the process should be used, how it should be staffed, and the process for its use.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published a draft regulation on February 22, 2022, to harmonize the QSR with ISO 13485:2016.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Turn bad data into great data in minutes!
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how users interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. Required documentation will be explained.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The company must establish a program where they identify, analyze and control cybersecurity risks for both pre-market and post-market.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses.
Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Software and related hardware design, development, verification, and validation are difficult to manage, document and control. This presentation focuses on the verification and validation planning and execution of software, after basic developmental testing and debugging. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel at the introductory level.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Ray Evans | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program to be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Skills to effectively manage, present and communicate data are now vital in the competitive financial and business analysis fields and offer vast opportunities to expand accounting client services and career paths.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The ability to analyze data is a powerful skill that helps make better decisions. Microsoft Excel is one of the top tools for data analysis and PivotTables is arguably the most popular analytic tool.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.
Speaker: Ray Evans | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will benefit all pharmaceutical & biotech professionals who work in QA, Compliance, Regulatory Affairs, Purchasing, and Supply Chain. This seminar will cover the importance of vendor qualification programs, and how well these programs can be implemented in a pragmatic & compliant manner.
Speaker: Nada Kuganathan | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will begin by defining value stream mapping and the key terms that comprise the VSM process. The purpose of VSM, important to participant focus, will also be discussed.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA steadily expands the scope and restrictions for the promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume you're talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this training, you’ll learn some powerful tips, tricks, and shortcuts to help you become more productive in your use of Excel.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"How do I look up a value in list ONE and pick up a related value from list TWO"
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
No matter what business you are in, a dashboard is a critical tool in your communication armoury and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it’s flexibility and the fact that most people have it installed on their computer.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you manufacture FDA-regulated drugs, devices, biologics, combination products, dietary supplements, or cosmetics the underlying reason FDA will inspect your facility is to determine if you are in control of all aspects of the operation. It is not enough to have SOPs that state what is supposed to happen. FDA starts with your products and then works backward to determine if all the pieces are in place. For contract manufacturers, the challenge grows exponentially as the number of clients and products increases.
Speaker: John Misock | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.
Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Good leaders walk the talk, but they also “write right”. They know how to say in a few words what needs to be said in crisp, clear language. The road to bad communication is paved with good intentions but poor construction. Readers know when subjects and verbs don’t agree when punctuation misses the point when words don’t fit, and content is confusing. In this session, learn how a few basic rules on grammar, punctuation, and usage can improve business written communications with clearer, more succinct content.
Speaker: Dev Strischek | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Verification and validation requirements have always been part of the US FDA’s GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Microsoft Outlook is a powerful productivity tool and if you are using it only for email and for keeping track of meetings and appointments, about 80-85% of the power of Outlook is unused. You paid a great deal for the privilege of using Microsoft Outlook - why not wring every dollar you can out of it?
Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Do you remember when hand-written letters or typed letters was the main means of communication? If so, you may also remember how glorious it was to send information and have immediately received via the fax machine.
Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Prioritizing is a fundamental time management principle and, in this webinar, you are taught the principles of prioritizing and how to work check off work right in your Inbox.
Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand and engaging.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances. This happens because FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment using real-world data to improve performance. Thus the field version of the software is no longer the validated approved version.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
In this seminar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule.
Speaker: Martin K. Behr, III | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.
Speaker: Yuval Shapiro | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The use of statistics in clinical trials insures a valid and robust study which minimizes bias in assessing the efficacy of new drug treatment or medical devices.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Speaker: Dennis Taylor | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Bioassays are used to demonstrate that a biological product performs per the stated function and potency.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.
Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The first four C’s-capacity, conditions, collateral, and character- evaluate a borrower’s ability to repay, but character forces the lender to examine closely the borrower’s willingness to repay.
Speaker: Dev Strischek | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.
Speaker: Dev Strischek | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule.
Speaker: Martin K. Behr, III | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has become the de facto spreadsheet application for business.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
In this session, participants will learn how to visually represent your data using both traditional charts (bar charts, line charts etc.) as well as how to do the same using some of Excel's non-charting tools.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Speaker: Charles H. Paul | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The subject of this webinar is building the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is about effective communication inside and outside of the project team.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The first step in catapulting your career ahead of your competitors is fully to use Microsoft Outlook.
Speaker: Karla Brandau | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Many laboratories have successfully developed and implemented a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs.
Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.
Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Design Control is considered a critical process by the FDA. Yet, is still a common source of 483 and Warning Letter observations.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
Speaker: Joy McElroy | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.
Speaker: Yuval Shapiro | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.
Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.
Speaker: Joy McElroy | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.
Speaker: Yuval Shapiro | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified.
Speaker: Steven Wachs | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The use of statistics in clinical trials insures a valid and robust study which minimizes bias in assessing the efficacy of new drug treatment or medical devices.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Once a customer has been acquired, an organization needs to maximize the lifetime value of the relationship. This course will explore the following topics:
Speaker: Robert Greene | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
You need to eradicate racism in the workplace and promote unity. Learn how to build an inclusive and equitable organization, ensure fairness for all employees, candidates, customers, and other stakeholders.
Speaker: Robert Greene and Marques Ogden | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Recently, OSHA issued over 40,000 citations for safety violations in the workplace. In one example, a HVAC company was fined over $1.2 million for recordkeeping violations.
Speaker: Deidre Tate | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
This seminar will begin with a general discussion of technical writing and its role within the life sciences.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Speaker: Tom Fragale | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements.
Speaker: John E Lincoln | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
FDA’s import and export programs are complex, detailed and undergo changes without notice to the public.
Speaker: Casper Uldriks | View Anytime | Duration: 2 Days | Price: $1,045.00 | View Details
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider.
Speaker: Adriaan Fruijtier | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Statistics is a useful decision making tool in the clinical research arena.
Speaker: Elaine Eisenbeisz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits. Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water microbiology.
Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it.
Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will review the regulatory requirements for investigating an OOS Investigation.
Speaker: Danielle DeLucy | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Mr. Yuval Shapiro shall present the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.), and the common practice.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Due to the growth of electronic records and electeronic signatures in CGMP documentation, as well as computer-controlled manufacturing, and medical devices, the US FDA has issued a draft Guidance for Industry, outlining its expectations for increased data integrity in this changing environment.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Due to the growth of the cybersecurity threat to electronic records, computer-controlled manufacturing, and medical devices, the US FDA has issued Guidances for Industry, e.g.: 1) "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Document”, and 2) "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and 3) "Postmarket Management of Cybersecurity in Medical Devices" - Draft.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Some of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Learn how to quickly spot violations in the workplace and how to correct them to OSHA standards by attending this webinar.
Speaker: Deidre Tate | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes. The United States-Mexico-Canada Agreement (USMCA), commonly referred to as the "New NAFTA," is essentially “NAFTA 2.0".
Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Advancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule.
Speaker: Martin K. Behr, III | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techniques, keyboard shortcuts, hidden menus, and even ways to create your own custom keyboard shortcuts in Excel.
Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Excel expert David Ringstrom, CPA, shows you how to implement internal control features within your Excel spreadsheets in this enlightening presentation. David uses a simple invoice form as a teaching aid to present various ways to control users' actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes. David demonstrates every technique at least twice first, on a PowerPoint slide with numbered steps, and second, in Excel 2016. He'll draw to your attention any differences in Excel 2013, 2010, or 2007 during the presentation as well as in his detailed handouts. David also provides an Excel workbook that includes most of the examples he uses during the webcast.
Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View DetailsWe often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
For years the IRS has struggled with the independent contractor and tax collection.
Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This 60-minute webinar will cover the proposed FDA traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls.
Speaker: John Ryan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This webinar will help you avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The circumstances surrounding the coronavirus are continuing to develop each day, and with the rapid-fire nature of the modern media, details vary from broadcast to broadcast, leaving the audience in fear and confused as to what next steps they should take. Having a plan is the best course of action, and with the changing national condition, employers are feeling the pressure of growing concern.
Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The outbreak of coronavirus disease (COVID-19), first in the People's Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries.
Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The term, Incoterms®, is an abbreviation for International Commercial Terms.
Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Is managing your Inbox and digging out from an avalanche of emails a full time job? Then sign up for this webinar and learn how to survive the heavy load of tasks and the constant stream of trivia that arrives via email.
Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.
Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this informative webcast, Excel expert David H. Ringstrom, CPA, introduces you to the concept of Microsoft Excel dashboards.
Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The FDA’s expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
The webinar will provide important considerations when selecting sample sizes for specific applications.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes.
Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
A sampling plan is a term widely used in research studies that provide an outline on the basis which of research is conducted. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the population.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
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