As FDA scrutiny of artificial intelligence (AI) in GxP systems accelerates, life science companies are under growing pressure to demonstrate robust controls, validation, and quality oversight for AI-enabled tools used in manufacturing. This inaugural session of Pharma in Focus: The Regulatory Issues Everyone is Talking About will explore these expectations through a timely case study: the FDA Warning Letter to Purolea and what it signals about the use of AI in the manufacturing environment.

Using the Purolea letter as a jumping-off point, our speakers will examine how FDA’s evolving AI posture intersects with cGMP requirements, data integrity, quality unit responsibilities, and inspection readiness. The discussion will connect recent FDA draft guidance on AI used to support regulatory decision-making with practical, shop-floor realities for pharmaceutical and biopharmaceutical manufacturers.

Speakers

• Douglas Campbell: Principal, Campbell CGMP Services; Former U.S. FDA. Mr. Campbell brings deep inspection and enforcement experience, translating FDA expectations into actionable cGMP and quality system practices for manufacturers.
• Karen Zimm, Ph.D. Adjunct Professor, Temple University. Dr. Zimm offers an academic and regulatory affairs perspective, connecting case-based lessons from Purolea to broader trends in regulatory science, AI governance, and workforce training.

This one-hour, high‑impact session is designed for professionals in Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Validation, and Compliance who need to stay ahead of how AI is reshaping FDA expectations.