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Medical Device Lunch Briefing - FDA 483 Response Best Practices

Speakers:
  • Judith Meritz, J.D., YourEncore
  • Victor Chance, YourEncore

The receipt of a 483 at the conclusion of a facility inspection notifies a company of conditions the FDA believes are in violation of the Food, Drug & Cosmetic Act.  A company’s response to the 483 determines whether further enforcement action will result, in follow-up to the FDA’s mandate to protect public health.

In this session, Judith Meritz and Victor Chance will outline the most frequent deficiencies cited in a FDA 483 as well as highlight common pitfalls in the supply chain function when addressing compliance remediation issues.  

Judith and Victor will suggest the most effective method to draft a response, define root cause and develop corrective actions, in order to successfully allay FDA concerns and avert the issuance of a Warning Letter.


About Judith Meritz, JD:  Ms. Meritz is a Strategic Advisor and member of YourEncore’s Medical Devices Practice.  Previously, she was the Associate General Counsel at Covidien/Medtronic and specializes in compliance counseling concerning FDA and other international regulatory authority matters including inspections, enforcement actions, product approval strategies, marketing and advertising programs, and complaint handling.  Prior to assuming her current role, she served as partner at a top Washington, DC law firm and Assistant General Counsel for the American Red Cross, in addition to VP of Regulatory Affairs for mid-sized medical device manufacturers and distributors.

About Victor Chance:  Mr. Chance is a Strategic Advisor and member of YourEncore’s Medical Devices Practice.  Previously, he was the Vice President of External Operations and Chief Supply Chain Chief Procurement Officer for J&J Medical Devices and Diagnostics. There he was responsible for the external supplier network and all associated performance improvement initiatives. Mr. Chance also served as Worldwide Vice President of Operations for J&J’s Cordis franchise, responsible for directing the company’s global manufacturing, supply chain management and strategic sourcing functions.