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GAMP®

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A GAMP® Guide to Computerized Systems Compliance

Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods...
Training

GAMP® Data Integrity 21 CFR Part 11 2-Day Training Course (T70)

The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result....
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Requirements for Computerized Systems Validation and Compliance

This online course describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except for the...
Training

GAMP® Data Integrity 21 CFR Part 11, 3-Day Training Course (T50)

This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.
Online Training course

Integrating Data Integrity within a Risk-Based approach to Compliant GxP Process Control Systems (T21)

This highly interactive classroom course describes how the GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Process Control Systems, and GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records  may be applied to achieve process control systems that are fit for intended....
ISPE Online Training

GAMP 5®, Annex 11/Part 11 Basic Principles Training Course (T45)

This classroom or online course has been updated to include the new revised GAMP® Second Edition as well as a discussion on the application of AI/ML. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device....
Training

GAMP® Basic Principles Training Course (T07)

This classroom or online course has been updated to include the new revised GAMP® 5 Second Edition as well as a fundamental discussion on framing the application of AI/ML in regulated spaces. This fundamental course introduces participants to regulatory requirements for computerized systems in the....