Annex 11 Update: What the 2025 Draft Means for Your GxP Systems
Description
The long-awaited update to EU-GMP Annex 11 is here – and it’s more than just a refresh. With the draft released in July 2025, this revision reflects the major shifts in digital technology, regulatory expectations, and risk-based compliance.
From AI accountability to SaaS oversight and immutable audit trails, the updated Annex introduces 17 structured sections that redefine how computerized systems are managed in GxP environments.
In this live webinar, our experts will break down what’s new, what’s changed, and how you can align your systems, SOPs, and validation strategies with the future of compliance.
Agenda
1. Introduction & Context
2. Annex 11 in Transition
- Why Annex 11 matters in 2025
- From 2011 to 2025: What’s changed and why
3. Key structural and content shifts
4. Practical Implications
- What to revisit in your SOPs
- Preparing for inspection-readiness
5. Live Q&A with our Experts
Why Attend?
- Understand the key changes in the 2025 Annex 11 draft
- Identify areas in your SOPs that may require updates
- Prepare for inspections with greater confidence and clarity
Click here to register for the free webinar: https://www.bigmarker.com/gxp-cc/annex-11-update-what-the-2025-draft-means-for-your-gxp-systems