Live online training with QFINITY

On 8 May 2026, the live online training “GxP Systems & Digital Compliance Fundamentals” will take place. QFINITY CEO Oliver Herrmann will deliver the training together with Martin Heitmann. The focus will be on AI compliance, GMP requirements, Annex 11 and the Annex 22 Draft. Practical approaches for the safe use of AI in regulated GxP environments will also be presented.

Artificial intelligence is increasingly being introduced into GMP-relevant processes and systems. This creates new opportunities, but also new requirements for validation, data integrity, governance and inspection readiness. The training addresses precisely this interface. It provides fundamentals and current developments relating to computerised systems and digital compliance. In addition, the session covers the regulatory-compliant use of AI in the GMP environment.

Participants will receive a structured overview of the requirements of the current Annex 11. The possible impact of the revised Annex 11 drafts will also be discussed, as well as new regulatory perspectives arising from the Annex 22 Draft. In addition, the ISPE GAMP perspective on good practices for the quality of computerised systems will be included. A particular focus will be placed on the effective, safe and compliance-oriented use of AI in GxP environments.

The training will be delivered by Oliver Herrmann, CEO and Founder of QFINITY, and Martin Heitmann. Oliver Herrmann is internationally recognised as an expert in validation, technology quality, data integrity and system implementation. Martin Heitmann brings extensive expertise in GAMP AI and GxP compliance. Among other roles, he is Co-Lead of the ISPE GAMP Guide: Artificial Intelligence.

Further information about the training can be found here. Further events with and by QFINITY can be found under Meet QFINITY.