AI Governance in GxP: From Principles to Practice
AI Governance Imperative
Why traditional quality frameworks fall short for AI/ML systems and what a modern AI governance framework looks like in practice.
FDA & EMA Perspectives
Analysis of recent regulatory guidance from FDA and EMA on AI in pharmaceutical manufacturing, with practical interpretation.
Event at a Glance
280+
Registrations
75+
Unique Viewers
2,140
Minutes Watched
Dr. Sarah Mitchell
VP, Quality & Compliance, Merck
James Rodriguez
Director, AI Engineering, xLM Continuous Intelligence
45 Minutes ofPractical Insight
March 29, 2026
Full access session recording available on demand.
45 Minutes of Content
Candid discussion covering governance, compliance, and AI adoption in pharmaceutical manufacturing.
Detailed Event Overview
This session brought together AI governance experts to explore practical frameworks for implementing AI in GxP-regulated environments. The conversation covered how organizations can balance innovation velocity with compliance rigor.
Governance frameworks
How to build practical AI governance frameworks that satisfy FDA and EMA expectations while enabling innovation.
AI Center of Excellence
How to establish an AI CoE that bridges quality, IT, and business stakeholders for effective governance.
Regulatory documentation
Step-by-step guidance on documenting AI model lifecycle management for regulatory submissions.
Risk classification
How to classify AI/ML models under GAMP 5 risk categories in regulated environments.