Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems
This webinar will tell you more about the second edition of GAMP 5, which will provide updates, clarify the relationship between GAMP 5 and the GAMP® 5: Records and Data Integrity Guide, recognition of the FDA’s current work on computer software assurance (CSA), and an updated, dynamic and evolving set of Appendices.
Agenda
00:00Â – Introduction
05:44Â – GAMP background
15:50Â – 2nd edition drivers
21:19Â – New chapters
33:37Â – Updated and removed chapters
37:03Â – Conclusion + Q&A
Here's what you'll learn
A deep dive into the GAMP 5 second edition
What are the drivers of the GAMP 5 second edition and why is there no GAMP 6?
New, updated and removed chapters to the guidenace
Speaker
Yves Dène
CSV Specialist
Expert knowledge in Computer Systems Validation
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