Devaki Patel hosted the September 17 panel, “AI Meets CGMPs: Where Innovation Meets Accountability,” exploring the evolving role of AI in CGMPs, FDA’s emerging expectations for responsible AI use, and lessons from recent regulatory developments, including FDA’s 2026 warning letter addressing the use of AI in pharmaceutical manufacturing.
Attendees will gain practical insights into applying a risk-based approach to AI governance, maintaining meaningful human oversight, and leveraging AI as a tool to strengthen—not replace—the quality system.