CEO Jack Garvey will be participating in a panel discussion, “FDA’s Case for Quality in Medical Devices and Harmonization of Quality System Regulation,” as part of the Food and Drug Law Institute’s all-virtual Annual Conference October 8th at 2:30pm Eastern.
The premier conference for the food and drug law community, the FDLI Annual Conference addresses complex legal, regulatory, compliance, and policy issues in all facets of the FDA-regulated industry. The two-day event provides in-depth discussions and analyses on a wide variety of timely topics by bringing together experts from the federal government, industry, the private bar, non-profits, patient and consumer advocates, consulting organizations, and academia.
John C. (Jack) Garvey, Principal / Chief Executive Officer, Compliance Architects LLC
Marian J. Lee, Partner, Gibson, Dunn & Crutcher LLP
Francisco Vicenty, Case for Quality Program Manager, Office of Compliance, CDRH
Moderated by Neil P. Di Spirito, Member of the Firm, Epstein Becker & Green, P.C.
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.
Take advantage of this year’s discounted registration rates and sign up today: https://bit.ly/2ETm79V.