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Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems

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On demand
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1h
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Medical Devices, IVD, Pharma
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English
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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

Webinar - Second edition of GAMP 5 A Risk-Based Approach to compliant GxP Computerized Systems - QbD Group (1)

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