Setting up ATMP Quality Management Systems: Strategies for Compliance and Success
This webinar will tell you more about how to prepare effectively a Compliant ATMP Quality Management System. Discover the key elements required to establish and maintain a QMS that adheres to Eudralex Part IV regulations.
Gain valuable insights into the critical considerations involved in setting up and managing a QMS in alignment with Part IV guidelines. Don’t miss this opportunity to optimize your ATMP quality processes and ensure regulatory compliance.
Agenda
00:00 – Introduction
03:00 – QbD at a Glance
06:32 – ATMP
11:00 – QMS
30:32 – QbD methodology
51:00 – Key conclusions
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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