Online training
GxP Systems & Digital Compliance Fundamentals
From Annex 11 and GAMP 5 to Annex 22 and the ISPE GAMP Guide: Artificial Intelligence.
For QA, IT, CSV and regulatory affairs professionals in GMP-regulated companies. No prior AI knowledge required.
- Date
- Date currently being scheduled
- Format
- Live online · Taught in English · Approx. 4 hours
44
professionals attended the first run
approx. 4 h
live online in a single afternoon, no travel
8
modules from the fundamentals to the open Q&A
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 PMBreak
- 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 PMOfficial 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.
FAQ
Frequently asked questions
Prefer to talk first?
If you want to tackle this internally rather than book individual seats, we will work out an approach for your site.