Are the new EU GMP drafts changing how you manage documentation, computerised systems and AI?
About this Webinar
The European Medicines Agency draft updates to EU GMP introduce significant changes to Chapter 4 on documentation, a full revision of Annex 11 on computerised systems, and a new Annex 22 dedicated to Artificial Intelligence. These proposals signal a clear shift towards a more digital, data centric and tightly controlled GMP environment.
In this expert led Q&A session, Rephine specialists with extensive experience in GxP, computerised systems and inspections provide practical insight into what these draft changes mean in practice. The discussion focuses on regulatory intent, likely inspection expectations, and how pharmaceutical and life sciences organisations can prepare without overcomplicating their quality systems.
The session draws on real audit and inspection experience to clarify common questions around data integrity, cybersecurity, audit trails, cloud services and the acceptable use of AI within GMP processes.
The session will cover the following topics:
- Key changes to EU GMP Chapter 4 and the expanded definition of documentation formats
- What the revised Annex 11 means for computerised systems, audit trails and cybersecurity
- Regulatory expectations for suppliers, cloud services and data location
- The scope and limitations of Annex 22 and how Artificial Intelligence can be used responsibly in GMP
- Practical inspection expectations and common areas of regulatory focus
Watch the full webinar to understand how these EU GMP drafts may affect your organisation and how to prepare with confidence.
Agenda
00:02
Introduction and session overview
Introduction and session overview
09:10
EU GMP draft updates overview
Chapter 4, Annex 11 and the new Annex 22
EU GMP draft updates overview
Chapter 4, Annex 11 and the new Annex 22
12:05
Documentation, data integrity and hybrid systems
Documentation, data integrity and hybrid systems
14:41
Computerised systems, audit trails and
Computerised systems, audit trails and
cybersecurity expectations
20:34
Artificial Intelligence in GMP and Annex 22 explained
Artificial Intelligence in GMP and Annex 22 explained
24:48
Q&A
Inspection expectations, AI validation, suppliers and
Q&A
Inspection expectations, AI validation, suppliers and
cloud services
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