The increasing scrutiny of artificial intelligence (AI) by the FDA is prompting life science companies to enhance their regulatory compliance and quality oversight for AI tools in manufacturing. The inaugural session of "Pharma in Focus: The Regulatory Issues Everyone is Talking About" will delve into these challenges, centering around a case study of the FDA Warning Letter issued to Purolea, which highlights critical regulatory expectations.
During this session, experts will discuss how the FDA's evolving stance on AI aligns with current Good Manufacturing Practice (cGMP) requirements, emphasizing the importance of data integrity, quality unit responsibilities, and readiness for inspections. The conversation will also link recent FDA draft guidance on AI's role in regulatory decision-making to the practical realities faced by pharmaceutical and biopharmaceutical manufacturers on the ground.
The panel features Douglas Campbell, a former FDA official with extensive experience in inspection and enforcement, who will translate FDA expectations into actionable practices. Alongside him, Dr. Karen Zimm from Temple University will provide insights from both academic and regulatory perspectives, connecting lessons from the Purolea case to wider trends in regulatory science and AI governance.
This session is particularly relevant for professionals in Regulatory Affairs, Quality Assurance, and related fields, as it aims to equip them with knowledge about the evolving role of AI in regulatory frameworks and its implications for compliance and quality management in the life sciences sector.