Arcondis is hosting an exclusive virtual roundtable to discuss the most significant European Union’s (EU) Good Manufacturing Practice (GMP) updates in years, including the newly introduced Annex 22 on Artificial Intelligence. This event brings together QA, regulatory, digital transformation, and manufacturing leaders in life sciences to unpack what’s changing, what it means and how to prepare.
- Date: September 11, 2025
- Time: 14:00 – 16:00 CET
- Format: Virtual Roundtable via Teams (Dial-in details provided following event registration)
What to Expect
The 2025 EU GMP revisions signal a shift from static documentation to dynamic, data-driven quality systems.
We’ll explore:
Chapter 4 – Documentation
- Covers text, images, video, and hybrid formats
- Reinforces data integrity (ALCOA++)
- Enables risk-based control of digital records
- Clarifies responsibility for electronic signatures
Annex 11 – Computerised Systems
- Strengthens cloud and supplier oversight
- Supports agile validation approaches
- Introduces full lifecycle control of system requirements
- Expands audit trail and access control expectations
Annex 22 – Artificial Intelligence (NEW)
- First EU GMP guidance on AI in manufacturing
- Covers model design, training data, validation & monitoring
- Requires Human-in-the-Loop (HITL) oversight
- Prohibits LLMs & generative AI for GMP-critical tasks
Why Attend?
This is your chance to stay ahead of compliance expectations, share perspectives with peers, and contribute to the future of digital GMP practices.
How to Attend
Seats are limited. To request your invitation, please contact marketing@arcondis.com by August 30.