FDA, PDA Host 33rd Joint Conference on CGMP Quality

Data integrity risks, aging facility remediation, and supplier oversight are among the CGMP compliance themes FDA and the Parenteral Drug Association will address at their 33rd Joint Regulatory Conference, scheduled for September 9–11, 2024, in a format designed to move between regulatory signal and plant-floor application.

The three-day event runs daily from 7:15 a.m. to 5:00 p.m. ET and is structured around systemic, preventive approaches to CGMP compliance across the product lifecycle. FDA's Office of Compliance is a co-organizer, which positions the conference as a direct channel for understanding current agency expectations rather than a third-party interpretation of them.

Session topics span the operational and quality spectrum: building compliant quality systems, conducting robust investigations, managing cybersecurity and data integrity exposure, external supplier selection and auditing, and upgrading aging facilities. For QA directors, the inclusion of quality assurance authority implementation and quality control laboratory de-risking reflects areas where FDA inspection findings have concentrated in recent cycles.

The agenda also covers updates on the latest CGMP guidances and the use of current manufacturing technologies, giving regulatory affairs leads a structured opportunity to benchmark internal programs against evolving agency standards. International collaboration efforts and their implications for supply consistency are also on the program, relevant to any organization managing a global supplier base or multi-site manufacturing network.

The conference is open to pharmaceutical companies, regulatory agencies, academia, and manufacturing and quality professionals in the U.S. and internationally. An open discussion forum between FDA representatives and industry experts is built into the format, offering a direct line to agency thinking that rarely surfaces outside formal guidance documents or inspection outcomes.

Plant heads and QA directors tracking FDA's posture on industrial modernization and quality risk management will find the case study sessions particularly instructive, as they are designed to illustrate how sustainable compliance translates into supply consistency rather than one-time audit readiness.

Registration and program details are available through the PDA; FDA contact is Lorraine Wood, Office of Compliance, at [email protected], and PDA contact is Molly O'Neill, Vice President, Programs and Meetings, at [email protected].

The conference's explicit focus on preventive quality system architecture, read against the agency's sustained inspection pressure on data integrity and supplier controls, makes the September sessions a measurable checkpoint for compliance program alignment ahead of year-end audit cycles.

Source: FDA What's New: Drugs RSS Feed via FDA.gov, published August 28, 2026 (event date September 9–11, 2024).