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

00:00 – Introduction

05:44 – GAMP background

15:50 – 2nd edition drivers

21:19 – New chapters

33:37 – Updated and removed chapters

37:03 – 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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