Neil P. Di Spirito, Member of the Firm, will moderate a session, “FDA’s Case for Quality in Medical Devices and Harmonization of Quality System Regulation,” at the FDLI Annual Conference, which runs from October 6 to 8.
Launched in 2011, FDA’s Case for Quality seeks to improve medical device manufacturing by recognizing companies and identifying practices that consistently create high quality products, emphasizing quality system regulation as a tool for improving product quality. In this session, stakeholders will discuss the current state of FDA’s Case for Quality programs, including the Case for Quality pilot program and Corrective and Preventive Action Plan (CAPA) process improvement pilot study. Speakers will also discuss FDA’s harmonization of Quality System Regulation with the international quality systems standard ISO 13485 and the draft rule expected out this fall, including what manufacturers need to do to prepare.
For more information, please visit FDLI.org.