Why AI compliance is becoming one of the most critical regulatory issues facing the pharmaceutical industry.
AI systems in GxP environments are no longer a thing of the future—they are a reality. Yet the regulatory framework lags behind technological developments:
EU GMP Annex 11 was not designed for autonomous, learning systems – "black-box" models are virtually impossible to audit.
The EU AI Act establishes new obligations for high-risk AI systems in the life sciences industry that many companies are not yet aware of.
The ISPE GAMP Guide "AI" defines new global standards—the interpretation of which is still uncharted territory for most quality management teams.
Without a clear validation and data governance strategy, inspection findings are a risk in every AI-supported GxP process.
What to expect from the 4-hour intensive training session.
Compact, practical, and immediately applicable—four modules that will truly help you and your team move forward:
The current regulatory landscape.
What inspectors look for today when evaluating AI systems: the EU AI Act, GAMP standards, and the significance of the future Annex 22. A clear overview of the regulatory landscape that already affects your GxP AI systems today.
ISPE GAMP Guide "AI" – An Exclusive Look.
Straight from the authors: Interpretation and practical application of the new global standard for AI in regulated environments. What the guidelines require—and how to implement them in your organization.
Validation strategies (CSV/CSA) for AI.
How to make the "black box" nature of autonomous systems audit-ready. Proven approaches for machine learning models that evolve over time—without compromising their validation status.
Data Integrity & Governance for Self-Learning Systems.
Lifecycle management, data training concepts, and change management for self-learning software. How to ensure data integrity and traceability for AI models in the long term.
Two of Europe’s leading experts on AI compliance—with hands-on experience.
You won’t find this expertise in textbooks—but directly from the people who are actively shaping industry standards:
Oliver Herrmann.
Chair of the ISPE GAMP EU Steering CommitteeFor decades, he has been one of the most renowned pioneers and auditors in the field of IT compliance and computerized systems in the D-A-CH region. As Chair of the ISPE GAMP EU Steering Committee, Oliver Herrmann plays an active role in shaping the regulatory standards against which pharmaceutical companies are measured today.
Martin Heitmann.
Leading GAMP AI & GxP ExpertCo-leader of the ISPE GAMP guideline for artificial intelligence and a key architect of future AI governance concepts for the life sciences industry. Martin Heitmann applies the knowledge gained during the standard’s development process directly in practice.
Why this training is the most efficient way to build your AI compliance expertise.
Three reasons why compliance teams, quality managers, and IT validation specialists in the life sciences industry are investing in:
Exclusive knowledge.
You’ll learn directly from the authors of the GAMP AI Guide—no other training program offers this kind of access to the people who wrote the standard.
Ready to use.
All content is practical and tailored to real-world GxP environments—no abstract theory, but concrete recommendations for your next AI project.
Inspection reliability.
You’ll leave the training with a clear picture of where your company stands today—and what steps you need to take to be inspection-ready.