What happened
FDA and the Parenteral Drug Association (PDA) will host the 33rd Joint Regulatory Conference on September 9–11, 2024, emphasizing effective quality systems and an ongoing state of control across the product lifecycle. The program focuses on robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management as foundations for CGMP compliance. It will use case studies to address sustainable compliance, quality and supply consistency, and international collaboration. Planned discussion topics include investigations, cybersecurity and data integrity risks, supplier selection and auditing, current manufacturing technologies, CGMP guidance updates, aging facilities, quality assurance authority, and quality-control laboratory risk reduction.
Why it matters
For pharmaceutical manufacturers, the conference may matter because its agenda concentrates on maintaining control through quality systems and preventive management of manufacturing and supply-chain risks. The listed subjects connect practical compliance concerns—investigation robustness, supplier oversight, data integrity, facility modernization, laboratory risk, and quality assurance authority—with quality and supply consistency. The source presents these as discussion and case-study topics, not as new regulatory requirements.
Key topics: Effective quality systems and lifecycle state of control, Manufacturing and supply-chain risk management, Investigations, data integrity, suppliers, and facility modernization