Pharma 4.0: AI in GxP - From the rule books to your own documents

AI in GxP: From the Rule Books to Your Own Documents
A simpler day: one expert session, one hands-on workshop, and one conversation between the roles that make AI work.

Morning · 120 min · expert session What Changes When a Model Decides What a Human Sees EU GMP Chapter 4, Annex 11, and the new Annex 22 on AI appeared as drafts on 7 July 2025.1 Oliver shows what they ask of data, systems, and people, with cases from production, QC, QA, and validation. TAKE-HOME One picture for the day: data is the cargo, the system the truck, the model the autopilot, and the driver's seat is never empty.

Afternoon · 150 min incl. break · hands-on Putting AI to Work on DocumentationHeavy Processes A hands-on SOP case: faster to write, harder to get wrong. One SOP change, four rounds; after each, a short reflection puts every table level. Inspect sources Draft plain AI Set Up one source Sign approve TAKE-HOME A Next-Day Card with four actions and four questions for work the next day.

Close · 60 min · fireside chat Who Signs When AI Advises? People in different roles at one pharmaceutical company discuss AI and compliance, starting from what the tables found. One chair stays open for the room, as in a fishbowl. WHY THIS CLOSE In our May 2026 poll, the biggest fear was changing responsibility (49%). AI itself scored 10%.

Faciliated by ISPE Netherlands CoP Pharma 4.0