EU GMP Annex 11: Core Requirements & Upcoming Revision

May 8, 2025James FrancumDr. Ahyun Avery Hong

As regulatory expectations evolve, staying compliant with EU GMP Annex 11 is more important than ever – especially with a major revision on the horizon.

In this expert-led webinar, Dr. Avery Hong will walk you through the core compliance requirements of Annex 11 – elements that remain essential regardless of future updates. Topics include:

– Validation and risk management across the system lifecycle
– Audit trails, access control, data backup & recovery
– Responsibilities of suppliers and service providers
– Security, electronic records, and more

We’ll also look ahead:
– What do we know so far about the upcoming revision?
– How might new expectations around cloud services, IT security, and automation impact your systems?
– What steps can you take now to prepare?

And at the end of the session, we’ll share something special: an exclusive industry insight about a potential shift in how AI will be regulated in the EU GMP framework. This scoop isn’t public yet – so you’ll want to stay until the very end!

When?

May 22, 2025 | 4 p.m. Berlin (GMT +2:00)

If your role involves computerized systems, quality, validation, or data integrity, this webinar is a must.

If you have questions don´t hesitate to contact us!: Contact – GxP-CC