- 23
- April
- 2024
- Tuesday
Preventing Human Error in the Life Sciences
This webinar will describe the nature of human error in terms of how it is manifest and it distinct properties. As human error is directly related to human performance, we must discuss the contribution human performance has upon the inherent error that is performed by workers in life science settings. The impact of human error in manufacturing will be examined as a prelude to the discussion of human error investigation and root cause determination.
Charles H. Paul |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 23
- April
- 2024
- Tuesday
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 23
- April
- 2024
- Tuesday
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- April
- 2024
- Wednesday
Engineering Change Control
This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 25
- April
- 2024
- Thursday
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Robert J. Russell |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 25
- April
- 2024
- Thursday
Using Excel PivotTables to Easily Summarize and Analyze Data
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.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 26
- April
- 2024
- Friday
Risk Based Design Control Requirements and Industry Best Practices for Medical Devices
This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and within budget.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 26
- April
- 2024
- Friday
Device Changes, FDA Changes, and the 510(k)
The 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 Details
- 26
- April
- 2024
- Friday
FDA Audit Best Practices - Do's and Don'ts
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.
Charles H. Paul |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 26
- April
- 2024
- Friday
Excel - A Beginner's Guide to Formulas
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.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 26
- April
- 2024
- Friday
Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation
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.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 26
- April
- 2024
- Friday
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
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.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 29
- April
- 2024
- Monday
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations
This 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 Details
- 29
- April
- 2024
- Monday
Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data
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.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 29
- April
- 2024
- Monday
AI For Project Managers
AI for Project Managers: Boost Your Skills and Supercharge Your Projects
Dr. Kimberly N. West |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 29
- April
- 2024
- Monday
4-Hour Virtual Seminar on Bootcamp on Excel
In 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 Details
- 29
- April
- 2024
- Monday
Pivot Table Essentials for Data Analytics in Excel
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.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 29
- April
- 2024
- Monday
Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities
This 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 Details
- 30
- April
- 2024
- Tuesday
Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
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 Details
- 30
- April
- 2024
- Tuesday
Qualification of Contract Manufacturer Organizations Based on Practical Experience
"Regulatory agencies require that companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the CMO"
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 30
- April
- 2024
- Tuesday
The Human Error Toolbox: A Practical Approach to Human Error
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.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 30
- April
- 2024
- Tuesday
ChatGPT and Complex Financial and HR Conversations for Accountants
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.
Garrett Wasny |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 30
- April
- 2024
- Tuesday
Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA
“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.
Meredith Crabtree |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 30
- April
- 2024
- Tuesday
6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences
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.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 1
- May
- 2024
- Wednesday
Starting with Excel - the Vital Essentials
This 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 Details
- 1
- May
- 2024
- Wednesday
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 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 Details
- 1
- May
- 2024
- Wednesday
Excel - Mastering Lookup Functions
"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 Details
- 2
- May
- 2024
- Thursday
Data Integrity And Human Error
Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 2
- May
- 2024
- Thursday
Canva and AI - A Match Made In Heaven
This 90-minute course offers a deep dive into the synergy between Canva and AI, showcasing how this powerful combination can revolutionize your design process.
Dr. Kimberly N. West |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 2
- May
- 2024
- Thursday
Risk-Based Validation of Spreadsheet Applications
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. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 2
- May
- 2024
- Thursday
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and a live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP-compliant spreadsheet application.
David Nettleton |
Duration: 75 Minutes |
Price: ¤149.00
| View Details
- 2
- May
- 2024
- Thursday
Regulation Update Q1 2024: New and Proposed Regulations for Financial Institutions
In our world, regulations keep changing and we need to be able to adopt to them. It's really important for us to connect rules & regulations to roles in our organization. We are going to take a project management approach to recent rules & regulations and show how we need to act in order to effectively implement them
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 3
- May
- 2024
- Friday
Excel Linking Techniques with Word Powerpoint Access & Web
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.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 6
- May
- 2024
- Monday
Powerpoint Creating & Presenting a Complete Slide Show
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.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 6
- May
- 2024
- Monday
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 6
- May
- 2024
- Monday
Function, Preparation, and Execution of Job Aids in the Pharmaceutical Industry
Job 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: 60 Minutes |
Price: ¤149.00
| View Details
- 6
- May
- 2024
- Monday
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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.
Carolyn Troiano |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 7
- May
- 2024
- Tuesday
Strategic Error Mitigation: Standard Operating Procedures for Human Error Reduction
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
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 7
- May
- 2024
- Tuesday
The Transfer of Validated Methods
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.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 7
- May
- 2024
- Tuesday
Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data
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.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 8
- May
- 2024
- Wednesday
Excel - Quick Tips to Help You be More Productive
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?"
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 8
- May
- 2024
- Wednesday
Project Essentials of Setup Calendars Tasks Scheduling & WBS
Plan and initiate your projects with confidence, knowledge and consistency.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 8
- May
- 2024
- Wednesday
The Missing Link; The Quality of Front-End Services
Services make up some 75% of the overall economic activity. But this economic reality is not visible in quality management.
Willy Vandenbrande |
Duration: 75 Minutes |
Price: ¤149.00
| View Details
- 8
- May
- 2024
- Wednesday
Bank Enforcement Actions 2024: What happened and what Can We Learn
We will go through the different banking regulators and discuss recent enforcement actions. The goal of this training is to take away the lessons learned by prior enforcement actions, implementing changes within your compliance framework, continue with your risk mitigation efforts and manage your reputational risk when similar issues arise.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 9
- May
- 2024
- Thursday
21 CFR Part 11 - Compliance for Electronic Records and Signatures
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 9
- May
- 2024
- Thursday
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
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.
Robert J. Russell |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 10
- May
- 2024
- Friday
Outlook Email Calendar & Contacts Essentials Masterclass
Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 10
- May
- 2024
- Friday
Excel Basics - Data Visualization - Creating Effective Charts
"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 Details
- 13
- May
- 2024
- Monday
The Importance of Packaging and Labeling in Pharmaceutical Product Development
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.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 13
- May
- 2024
- Monday
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 14
- May
- 2024
- Tuesday
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 14
- May
- 2024
- Tuesday
Digital Assets & The Associated Compliance Risks
We must be aware of the compliance risks that are relevant with digital assets, specifically, cryptocurrencies. This regulatory landscape for cryptocurrencies is starting to move in the right direction and we could see some drastic movement in 2024. Justin will go through the recent developments to help you prepare in 2024
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 15
- May
- 2024
- Wednesday
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
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.
John E Lincoln |
Duration: 4 Hours |
Price: ¤445.00
| View Details
- 15
- May
- 2024
- Wednesday
How to Prepare for and Host an FDA Inspection and Respond to 483's
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 15
- May
- 2024
- Wednesday
Optimizing Efficiency: A Comprehensive Guide to 5S Principles
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.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 15
- May
- 2024
- Wednesday
Data Culture: What It Is and How to Make It Work
According to Forrester, organizations that use data to derive insights for decision-making are almost three times more likely to achieve double-digit growth.
Prashanth Southekal |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 15
- May
- 2024
- Wednesday
Excel Lookup Functions Xlookup & Error Suppression
Going “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 Details
- 15
- May
- 2024
- Wednesday
Fair Debt Collection Practices Act (FDCPA)
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.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 16
- May
- 2024
- Thursday
Analytical Method Validation Under Good Laboratory Practices - GLPs
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.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 17
- May
- 2024
- Friday
ChatGPT for Excel Essentials Made Easy
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.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 17
- May
- 2024
- Friday
Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Substandard 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 Details
- 17
- May
- 2024
- Friday
Device Changes, FDA Changes, and the 510(k)
The 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 Details
- 20
- May
- 2024
- Monday
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
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.
Mike Thomas |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 20 & 21
- May
- 2024
- Monday
2-Day Virtual Seminar on Effective Technical Writing in the Life Sciences
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.
Charles H. Paul |
Duration: 2 Days |
Price: ¤995.00
| View Details
- 21
- May
- 2024
- Tuesday
Medical Device Software Validation Meeting FDA Regulations
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 21
- May
- 2024
- Tuesday
ChatGPT for Excel Intermediate Masterclass
Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 22
- May
- 2024
- Wednesday
Excel - Reporting Simplified - Learn Pivot Tables from Scratch
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.
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 22
- May
- 2024
- Wednesday
Human Error Gen- Human Error Mitigation: Strategies for Enhanced Performance
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.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 22
- May
- 2024
- Wednesday
Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control
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. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 22
- May
- 2024
- Wednesday
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
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.
John E Lincoln |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 22
- May
- 2024
- Wednesday
AML Regulations 2024
It’s important to understand these changes, but we must also understand the implications for our financial institutions, particularly for individual staff members. This webinar will provide you the recent updates, relevant personnel impacted, and thoughts on updates to your internal documents.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 23
- May
- 2024
- Thursday
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 23
- May
- 2024
- Thursday
HPLC Analytical Method Development and Validation
Instrumental 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 Details
- 24
- May
- 2024
- Friday
Consumer Food and Health Attitudes 2024-2025
If your businee or industy addresses the needs of the consumer health, wellness, and food industries, this is a must see event.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 24
- May
- 2024
- Friday
Excel - Formulas and Functions 101
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.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- May
- 2024
- Friday
Using a Learning Management System (LMS) to Develop Pharma Training Curricula
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.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 24
- May
- 2024
- Friday
4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
Upon 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 Details
- 27
- May
- 2024
- Monday
3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
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.
Carolyn Troiano |
Duration: 3 Hours |
Price: ¤299.00
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- 27
- May
- 2024
- Monday
Excel - Essential Tips and Tricks for the New User
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.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
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- 28
- May
- 2024
- Tuesday
Building GMP Excellence: A Guide to Implementing Compliant Training Programs
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
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- 29
- May
- 2024
- Wednesday
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance
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.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
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- 29
- May
- 2024
- Wednesday
How to Deal with Bad Results Under GLP
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.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
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- 30
- May
- 2024
- Thursday
How to Write SOP's that Avoid Human Error
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.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
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- 30
- May
- 2024
- Thursday
ChatGPT for Innovative Business Advisory Services for Accountants
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
Garrett Wasny |
Duration: 60 Minutes |
Price: ¤149.00
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- 31
- May
- 2024
- Friday
Excel & ChatGPT Synergy Masterclass: Unleashing Financial Analysis Superpowers
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.
Garrett Wasny |
Duration: 90 Minutes |
Price: ¤149.00
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- 31
- May
- 2024
- Friday
Excel - A Beginner's Guide to Formulas
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.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
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- 31
- May
- 2024
- Friday
Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
This 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
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- 31
- May
- 2024
- Friday
Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities
This 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
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- 31
- May
- 2024
- Friday
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
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.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
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- 31
- May
- 2024
- Friday
Artificial Intelligence (AI) and Fraud: Exploring Risks and Opportunities
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.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 3
- June
- 2024
- Monday
Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA
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.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
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- 4
- June
- 2024
- Tuesday
Excel - Build Advanced Pivot Table Solutions Using the Data Model & PowerPivot
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.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
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- 4
- June
- 2024
- Tuesday
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification
This 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.
David Nettleton |
Duration: 2 Hours |
Price: ¤199.00
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- 7
- June
- 2024
- Friday
Introduction to Generative AI for Accountants
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.
Garrett Wasny |
Duration: 90 Minutes |
Price: ¤149.00
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- 10
- June
- 2024
- Monday
Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity
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.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
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- 10
- June
- 2024
- Monday
Excel - Build Even More Powerful Pivot Tables: DAX Essentials
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.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
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- 17
- June
- 2024
- Monday
Project Management for Computer System Validation (CSV) to Improve FDA Compliance
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.
Carolyn Troiano |
Duration: 60 Minutes |
Price: ¤149.00
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- 18
- June
- 2024
- Tuesday
Power BI Demystified: Transforming Data into Stunning Visuals
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”
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
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- 24
- June
- 2024
- Monday
Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance
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.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
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