Successful Workshop on “Implementing an AI Solution in a Pharma 4.0 Context”

At this year’s ISPE Annual Meeting & Expo 2025, aSuccessful Workshop on “Implementing an AI Solution in a Pharma 4.0 Context” successful GAMP & Pharma 4.0 Workshop took place, co-led by Frank Henrichmann together with Martin Heitmann, Brandi Stockton, and Paige Kane, PhD, CPIP, as well as several other experts.

Under the title “Implementing an AI Solution in a Pharma 4.0 Context,” around 100 highly engaged participantsdiscussed practical aspects of implementing Artificial Intelligence (AI) and Machine Learning (ML) in GxP-regulated environments — fully aligned with ISPE Pharma 4.0® and GAMP® principles.

The workshop focused in particular on:

  • Maturity assessment methods to evaluate organizational readiness for AI projects

  • Risk-based approaches in line with GAMP, specifically tailored to AI applications

The interactive format fostered lively discussions, knowledge sharing, and high-level peer-to-peer learning. Participants contributed diverse perspectives, questions, and real-world examples, resulting in a dynamic and insightful exchange.

Frank Henrichmann emphasized the importance of such events:

“Our community shows impressive commitment to moving beyond the buzzword of AI and creating real value — by connecting technology, processes, culture, and knowledge.”

QFINITY thanks all contributors and participants for their active involvement in this exceptional workshop and looks forward to further stimulating discussions and collaborations in the context of AI, Pharma 4.0, and GAMP.

For more information about this successful workshop and this year’s Annual Meeting, please visit ISPE’s website.