Webinar - Regulatory Evolution: What AI Means for GMP Manufacturing
A practical, inspector-informed look at what deploying AI in GMP-regulated environments really means: validation, human oversight, auditability, explainability, and the ongoing monitoring that traditional CSV was never designed for.
AI is moving from proof of concept into GMP-regulated manufacturing, and inspectors have noticed. Recent sessions with the FDA and UK MHRA have flagged the same pitfalls again and again: models that drift once deployed, unclear human oversight, and validation approaches built for static computerized systems being stretched to cover something they were never designed for.
This webinar cuts past the theoretical AI hype and focuses on what deploying an AI system in a GMP environment actually looks like in practice — what inspectors are currently examining, why AI needs deeper ongoing monitoring than traditional computerized systems, and the reminder that existing GMP requirements (user access, audit trails, change control) still fully apply to AI-enabled tools.
You do not need to be an AI expert to attend. If you own quality, validation, or regulatory compliance in a pharma or biotech manufacturing site, this session gives you a practical framework to prepare for the next wave of AI-related inspection findings.
What you'll learn
- What FDA and MHRA inspectors are currently looking at when AI shows up in a GMP environment
- Why AI systems require deeper, continuous monitoring compared with traditional computerized systems
- How to apply existing GMP requirements (user access, audit trails, change control, data integrity) to AI-enabled tools
- How risk-based validation (CSV / CSA) needs to evolve to handle model drift, bias, and continuous improvement
Speakers
Jan Appelmans, Senior Consultant Software Services, QbD Group