Online training
GxP Systems & Digital Compliance Fundamentals
From Annex 11 and GAMP 5 to Annex 22 and the ISPE GAMP Guide: Artificial Intelligence.
- Date
- Date currently being scheduled
- Format
- Live online · Taught in English · Approx. 4 hours
- Price
- 90 CHF
- 44 professionals attended the first run.
- For QA, IT, CSV and regulatory affairs professionals in GMP-regulated companies. No prior AI knowledge required.
AI in GMP: innovation without compliance is risk
- AI tools entering GMP environments without a validation strategy
- Annex 11 misunderstood in the AI context
- Annex 22 emerging but still unclear in practice
- Data integrity risks amplified by large language models
- Inspectors asking new questions that have no clear answers
What you will be able to do
- Understand GMP computerised systems under the current Annex 11
- Navigate the revised Annex 11 draft and what changes
- Get an overview of ISPE GAMP guidance for good practice
- Know the Annex 22 draft and its key topics
- Use AI safely and effectively in a GxP environment
- Clarify open questions directly with the trainers
Agenda
1:00 PM
Primer, welcome & agenda
- Welcome and introduction of the trainers
- Introduction to GxP systems and digital compliance
1:20 PM
GMP computerised systems & current Annex 11
- Regulatory requirements and expectations
- Background and key changes of the Annex 11 revision
1:50 PM
Future of GMP compliance: revised Annex 11 draft
- Key GAMP concepts: lifecycle approaches and risk management
- Critical thinking and scaling in practice
3:05 PM
Break
3:20 PM
New horizons in GxP regulation: Annex 22 draft
- Scope and key topics of Annex 22
- Industry reflection and regulatory feedback
4:05 PM
Industry guidance: using AI safely and effectively
- Insights from GAMP 5 (2nd edition) and the ISPE GAMP Guide: Artificial Intelligence
- Regulatory context and practical relevance
4:35 PM
Open Q&A with the trainers
- Live Q&A across all topics of the training
4:55 PM
Official closing
Your trainers
Two of Europe's leading experts on GMP compliance and AI governance.
Oliver Herrmann
Computerized Systems Compliance Expert
- Chair of the ISPE GAMP EU Steering Committee
- Over 80 GxP audits performed
- Qualified ISPE GAMP trainer
- Decades of experience in CSV, GxP and Annex 11
- Hands-on support during GMP inspections
Martin Heitmann
AI Compliance Expert
- Secretary of the GAMP Global SIG Software Automation & AI
- Co-lead of the ISPE GAMP Guide: Artificial Intelligence
- Extensive publications on AI in GxP
- Co-author of AI guidance for regulated pharmaceutical companies
Why this training
- Led by members of the GAMP Steering Committee
- Based on real AI validation projects
- Directly linked to the ISPE GAMP Guide: Artificial Intelligence
- Inspection-oriented, not theory only
- Designed for practical application
For sign-off by your employer
- You receive a certificate of completion for your training record.
- Ticketing issues a receipt you can submit for reimbursement.
- Half a day with no travel time: the training runs fully online.
Approx. 4 hours of live training (1:00 PM to 5:00 PM CET) · Presentation slides · Certificate of completion · Interactive Q&A session with the trainers
Date being scheduled
The next run is currently being scheduled. Leave your email address and we will let you know as soon as the date is set, before it is announced publicly.
Frequently asked questions
- Is this relevant for non-technical professionals?
- Yes. This training is designed for QA, compliance and regulatory affairs professionals, not just data scientists. You will gain a practical understanding of AI risks and governance without needing to build AI models.
- Which language is the training held in?
- The training is held in English. You are welcome to ask questions in German during the Q&A.
- Will the EU AI Act be covered?
- 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.
- Will the session be recorded?
- No. It is a live, interactive session that we do not record, so discussion can stay open. Slides and materials are provided afterwards.
- Is this focused on GMP only?
- Primarily yes. The regulatory focus is GMP and GxP. However, many principles such as risk-based AI validation and governance frameworks apply across regulated industries.
- Is prior AI knowledge required?
- No. We begin with the fundamentals and build up step by step. The training is accessible to professionals new to AI who have GMP and compliance experience.