GAMP & Pharma 4.0 Workshop “Implementing an AI Solution in a Pharma 4.0 Context”
At the ISPE Annual Meeting & Expo 2025, Frank Henrichmann co-led the GAMP & Pharma 4.0 workshop ‘Implementing an AI Solution in a Pharma 4.0 Context’ with Martin Heitmann, Brandi Stockton, and Paige Kane – around 100 participants discussed maturity assessment and risk-based GAMP approaches for AI.
At this year’s ISPE Annual Meeting & Expo 2025, a successful GAMP & Pharma 4.0 workshop took place – co-led by Frank Henrichmann with Martin Heitmann, Brandi Stockton, and Paige Kane, PhD, CPIP, and several other experts.
Understanding AI not as a buzzword but as real value – by connecting technology, processes, culture, and knowledge.
Titled “Implementing an AI Solution in a Pharma 4.0 Context,” the workshop brought together around 100 highly engaged participants to discuss 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:
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Maturity assessment methods to evaluate organizational readiness for AI projects
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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 more stimulating discussions and collaboration around AI, Pharma 4.0, and GAMP.
For more information about this successful workshop and this year’s Annual Meeting, please visit ISPE’s website.
