GxP Systems & Digital Compliance Fundamentals
Master AI validation and compliance under Annex 11 & Annex 22 – practical, regulatory-aligned, implementation-ready.
AI in GMP – Innovation without Compliance is Risk.
- AI tools entering GMP environments without validation strategy
- Annex 11 misunderstood in AI context
- Annex 22 emerging but unclear in practice
- Data integrity risks amplified through LLMs
- Inspectors are asking new questions
"This training prepares you for inspection-ready AI."
What You Will Master
After this session you will:
Understand GMP computerised systems fundamentals as per current Annex 11
Navigate the revised Annex 11 draft and its future implications
Get an overview of ISPE GAMP guidance for good practices
Explore new horizons in GxP regulation via the Annex 22 draft
Learn how to use AI safely and effectively in GxP as a starting point
Participate in an open expert Q&A session
Training Agenda
Three focused modules covering the full AI compliance landscape in GMP.
Primer, Welcome & Agenda
GMP Computerised Systems & Current Annex 11
Future of GMP Compliance: Revised Annex 11 Draft
ISPE GAMP Guidance: Good Practices for Computerised System Quality
Conquering New Horizons in GxP Regulation: Annex 22 Draft
Industry Good Guidance: Using AI Safely & Effectively
Open Q&A with Your Experts
Your Trainers
Learn from two of Europe's foremost experts in GMP compliance and AI governance.
Oliver Herrmann
One of Europe's leading GAMP and computerized systems compliance experts.
- Chair ISPE GAMP EU SC
- Over 80 GxP audits performed
- Qualified ISPE GAMP Trainer
- Decades of CSV, GxP and Annex 11 experience
- Frontline GMP inspection support
Martin Heitmann
One of the architects of AI guidance in regulated pharma.
- One of Europe's leading GAMP AI / GxP compliance experts
- Secretary of GAMP Global SIG Software Automation & AI
- Co-lead of ISPE GAMP Guide: Artificial Intelligence
- Published extensively on AI in GxP
- Bridging innovation and compliance at scale
Why This Training is Different
Invest in Compliance
GxP Systems & Digital Compliance Fundamentals
What's Included
- Approx. 4h live training (1:00 PM – 5:00 PM)
- Presentation slides
- Certificate of completion
- Interactive Q&A session with your experts
Limited seats to ensure interactive format.
Frequently Asked Questions
Yes. This training is designed for QA, compliance, and regulatory professionals — not just data scientists. You will gain a practical understanding of AI risks and governance without needing to build AI models.
Yes, briefly. We focus on GMP-specific regulation (Annex 11, Annex 22) but reference the EU AI Act where it intersects with pharma compliance obligations.
No. This is a live, interactive session. We provide slides and materials after the event, but the session itself is not recorded to encourage open discussion.
Primarily yes. The regulatory focus is GMP and GxP. However, many principles (risk-based AI validation, governance frameworks) apply across regulated industries.
No. We begin with foundational concepts and build up. The training is accessible for professionals who are new to AI but experienced in GMP/compliance.
Any Questions?
Send us a message and our team will get back to you shortly.