CGMPs for Combination Products–Final Rule and Implementation: An Interactive Analysis with Industry and FDA
In the wake of the U.S. Food and Drug Administration (FDA) issuing the final rule on current Good Manufacturing Practices (CGMPs) for combination products, the Combination Products Coalition (CPC), in collaboration with the Regulatory Affairs Professionals Society (RAPS), will be hosting an interactive session examining the contents of the final rule and the agency’s implementation plan.
During the program, happening on Thursday, February 28th at the RAPS Training Center in Rockville, MD, attendees will hear directly from experts at each of the FDA centers and industry regarding what the final rule includes, with an emphasis on deviations from the proposed rule. In-person attendees will work with industry peers in case study breakout sessions, where they will have the opportunity to apply the final rule, analyze the rule’s remaining ambiguities and identify approaches for effective implementation. During the final recap session, the expert facilitators will present and connect major themes identified during the breakouts, and all attendees will have the opportunity to provide feedback directly to the experts at the various centers responsible for developing the implementation guidance regarding any other ambiguities not addressed in the case studies.
CPC and RAPS will collaborate to compile the major themes that emerge from the program regarding implementation and submit them to FDA for consider in developing its implementation guidance.
The program is intended for manufacturers (including contract manufacturers), combination product developers, consultants and legal counsel who are involved in regulatory, quality and compliance at all professional levels and can be attended in person or via webcast. For more information and to register, please visit the RAPS event page. As capacity for this event is limited, early registration is encouraged!