Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Roger Cowan | Duration: 60 Minutes | Price: $149.00 | View DetailsThis 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.
Robert J. Russell | Duration: 3 Hours | Price: $299.00 | View DetailsWhat 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.
Charles H. Paul | Duration: 2 Days | Price: $995.00 | View DetailsAlthough 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.
Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View DetailsSubstandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.
Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View DetailsThis 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.
John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View DetailsUnderstand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.
Ray Evans | Duration: 90 Minutes | Price: $149.00 | View DetailsThis 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.
Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View DetailsEmbark 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.
Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View DetailsThis 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.
Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View DetailsThis 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.
Charles H. Paul | Duration: 3 Hours | Price: $299.00 | View DetailsIt 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.
John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View DetailsAI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View DetailsIt 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.
Roger Cowan | Duration: 60 Minutes | Price: $149.00 | View DetailsInstrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View DetailsSupervision 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.
Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View DetailsA customised practical Excel Worksheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Ray Evans | Duration: 90 Minutes | Price: $149.00 | View DetailsValidation is an important element of the Quality System Regulations and ISO13485.
Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View DetailsThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View DetailsIn today's world, there are a ton of data to manage. Data is coming from many different sources.
Tom Fragale | Duration: 4 Hours | Price: $445.00 | View DetailsSetting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.
Alan M Golden | Duration: 60 Minutes | Price: $149.00 | View DetailsLearning 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.
Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View DetailsThis 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.
Charles H. Paul | Duration: 2 Days | Price: $995.00 | View DetailsIn 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.
Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View DetailsThis course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
John E Lincoln | Duration: 6 Hours | Price: $545.00 | View DetailsA customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Ray Evans | Duration: 90 Minutes | Price: $149.00 | View DetailsThis session is designed to provide an understanding of the importance of project chartering and defining primary metrics as foundational steps for successful process improvement initiatives.
Jim Athon | Duration: 60 Minutes | Price: $149.00 | View DetailsIn 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.
Alan M Golden | Duration: 60 Minutes | Price: $149.00 | View DetailsHuman error is known to be the primary cause of quality and production losses in many industries.
Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View DetailsThis webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View DetailsThis combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View DetailsA customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Ray Evans | Duration: 90 Minutes | Price: $149.00 | View DetailsHuman 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.
Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View DetailsA 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.
Roger Cowan | Duration: 60 Minutes | Price: $149.00 | View DetailsAssessment of the cause for a non-compliance is a structured series of branching questions.
John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View DetailsThis webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View DetailsIf 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.
Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View DetailsThe 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.
Carolyn Troiano | Duration: 6 Hours | Price: $545.00 | View DetailsThis 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.
Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View DetailsOften 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.
Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View DetailsThe 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.
Carolyn Troiano | Duration: 6 Hours | Price: $545.00 | View DetailsJob aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View DetailsThere has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.
John E Lincoln | Duration: 6 Hours | Price: $545.00 | View DetailsValidation is an important element of the Quality System Regulations and ISO13485.
Susanne Manz | Duration: 3 Hours | Price: $299.00 | View DetailsThis webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Ray Evans | Duration: 90 Minutes | Price: $149.00 | View DetailsThis course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View DetailsThis 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.
John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View DetailsThis 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.
Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View DetailsEnvironmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Roger Cowan | Duration: 60 Minutes | Price: $149.00 | View DetailsThis webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.
David Nettleton | Duration: 90 Minutes | Price: $149.00 | View DetailsHuman error is known to be the primary cause of quality and production losses in many industries.
Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View DetailsScientific 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.
Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View DetailsThis workshop is about understanding what is behind the Monte Carlo Simulation.
Isaac Gottlieb | Duration: 60 Minutes | Price: $149.00 | View DetailsIn 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.
Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details"How do I look up a value in list ONE and pick up a related value from list TWO"
Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View DetailsThis 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.
Robert J. Russell | Duration: 60 Minutes | Price: $149.00 | View DetailsThere has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance.
John E Lincoln | Duration: 4 Hours | Price: $445.00 | View DetailsThis 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.
Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View DetailsThe 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.
Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View DetailsOccupying 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.
Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View DetailsThis 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.
Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View DetailsAn 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.
Mike Thomas | Duration: 3 Hours | Price: $299.00 | View DetailsHuman 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.
Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View DetailsGoing "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
Ray Evans | Duration: 90 Minutes | Price: $149.00 | View DetailsThis webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View DetailsThe purpose of this workshop is to use the features of the data ribbon and the PivotTable of Excel for what we call datamining.
Isaac Gottlieb | Duration: 60 Minutes | Price: $149.00 | View DetailsIf 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.
John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View DetailsThis webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.
Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View DetailsThis webinar is about effective communication inside and outside of the project team.
Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View DetailsFew 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?"
Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View DetailsThis 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.
Robert J. Russell | Duration: 3 Hours | Price: $299.00 | View DetailsSubstandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.
Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View DetailsThis webinar will describe the nature of human error in terms of how it is manifest and it distinct properties.
Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | 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.
Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View DetailsAI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View DetailsLearning 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.
Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View DetailsIn this seminar, you will learn how to take your raw data and create meaningful reports using the powerful tools in Microsoft Excel.
Tom Fragale | Duration: 4 Hours | Price: $445.00 | View DetailsFDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
John E Lincoln | Duration: 3 Hours | Price: $299.00 | View DetailsSolver is a Microsoft Excel add-in program you can use for what-if analysis. Use Solver to find an optimal (maximum or minimum) value for a formula in one cell - called the objective cell - subject to constraints, or limits, on the values of other formula cells on a worksheet.
Isaac Gottlieb | Duration: 60 Minutes | Price: $149.00 | View DetailsThis 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).
Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View DetailsOne 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.
John E Lincoln | Duration: 4 Hours | Price: $445.00 | View DetailsIn 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.
Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View DetailsThis 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.
Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View DetailsAlthough 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.
Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View DetailsInstrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View DetailsThis 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.
Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View DetailsAssessment of the cause for a non-compliance is a structured series of branching questions.
John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View DetailsThis combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View DetailsThis webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View DetailsHuman 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.
Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View DetailsIf 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.
Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View DetailsOne 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.
John E Lincoln | Duration: 4 Hours | Price: $445.00 | View DetailsThis interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s.
David Nettleton | Duration: 75 Minutes | Price: $149.00 | View DetailsThis Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure.
David Nettleton | Duration: 2 Hours | Price: $199.00 | View DetailsThis webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.
David Nettleton | Duration: 90 Minutes | Price: $149.00 | View DetailsTopic: Not Specified
Category: All
Speaker: All
Month: Any