In this 45-minute webinar, you’ll get a practical walkthrough of the major changes coming with EU GMP Annex 11 and the new Annex 22. Learn what regulators expect when it comes to cloud systems, data governance and AI.
With Annex 11 being updated for the first time since 2011, and Annex 22 introducing the first formal expectations for AI, the next revision of EU GMP is the most significant in decades.
But what do these changes actually mean in practice?
Join Epista Life Science and Henrik Johanning for a practical session where we’ll cover the essentials of both annexes – and what you should do now to stay inspection-ready.
You’ll discover:
✅ The most significant changes in Annex 11
✅ What Annex 22 means for AI, machine learning and explainability
✅ What regulators expect when you use SaaS or AI-based tools
Key Takeaways:
These changes aren’t just regulatory formalities. They reshape what compliance looks like across IT, QA and data science – and place new demands on your teams, processes and suppliers.
.png)
Join our mailing list to be notified about upcoming events, receive valuable invitations, articles, surveys and the like.
