Surviving Medical Device Recalls

Product recalls are a reality. Knowing how to handle a recall can minimize what could be devastating results for your company. The FDA/CDRH Office of Compliance is committed to educating manufacturers on how to manage a recall successfully. Experts will review FDA regulations and discuss FDA procedures related to recalls. Insights on FDA thinking about the Health Hazard Evaluation process and classification of recalled products will be shared along with tips on Dos and Donts of the process.

 

Objective:
To review, discuss, and give insights relating to the medical device recall process.

 

Why should I take this eConference?
This eConference will help firms prepare for recalls and manage them successfully to minimize the disruption to business and to the health and safety of their customers.

 

You will learn:
1. About the FDA recall process including both the regulatory background and procedures
2. How to determine when a recall is needed
3. What steps are needed to implement the recall working successfully with the FDA
4. How to assess the risk that device defects pose
5. How to anticipate the likely classification of a recall
6. How to manage the recall to minimize the risk to the health of your customers

 

Who should attend:
Device manufacturers regulatory affairs, product safety, quality systems, manufacturing management and clinical representatives may find this especially useful. In vitro diagnostics will be addressed along with other medical devices.

 

What you will receive:
1. Slides
2. Expert speakers from FDA/CDRH Office of Compliance
3. A chance to listen to other's Q&A 
4. CEUs & Certificate

 

Presenters:
Kimber C. Richter, M.D.
Dr. Richter is Deputy Director for Medical Affairs in the Office of Compliance, in the Center for Devices and Radiological Health (CDRH), Food and Drug Administration. She provides clinical guidance to the Office and Center on device safety and policy issues, and conducts risk assessments of post market device failures and significant recalls. She participates in policy development on Data Integrity and Human Subject Protection issues for device research. She participates in policy setting on device-related tissue/combination product issues. Dr. Richter previously served as the Deputy Director for Clinical and Review policy in the Office of Device Evaluation, responsible for pre-market reviews and policy development for many devices. She participates in global harmonization activities (GHTF) and standards development for clinical trials. Dr. Richter joined FDA in April of 1995. Previously she held medical and senior management positions in major corporations. Dr. Richter completed her undergraduate studies at the University of Wisconsin and earned her M.D. from the University of Cincinnati in 1979.

 

Michael J. Verdi
Mr. Verdi began his career with the Food and Drug Administration in September 1977, as a Field Investigator inspecting all categories of regulated products in Richmond, Virginia, from 1977 until 1987. From 1987 until 1995 he specialized his work in sterile drug/device operations as the resident in charge of the Des Moines, Iowa, FDA Office. In this time period he also performed inspections for the FDA in foreign pharmaceutical sites of both bulk and finished drugs. In 1995 he moved to the Center for Drugs, Office of Compliance, as a Compliance Officer, reviewing both domestic and foreign inspections, for regulatory action. In April of 1996 he transferred within the Center to take the position of Recall Coordinator/Drug Shortage Manager, which involves classification and trending of U.S. Human drug recalls, and establishing policy/procedures to avoid drug shortages in the United States.

 

Betty Collins
Betty Collins is the Director, Division of Enforcement A, Office of Compliance, Center for Devices and Radiological Health. She manages nine medical device product areas that are handled by four Branches. These branches include General Surgery Devices Branch, Dental, Ears, Nose and Throat and Ophthalmic Devices Branch, Obstetrics, Gynecology, Gastroenterology and Urology Devices Branch and General Hospital Devices Branch. Prior to this position she served as the Chief, for the In-Vitro Diagnostics Devices Branch in the Office of Compliance for 11 years. Betty’s responsibilities include ensuring the safety and health of consumers who use medical devices by enforcing the Food, Drug and Cosmetic Act, and the Medical Device and Radiological health laws and regulations. Ms. Collins has been with CDRH over fifteen years. Prior to coming to CDRH she worked in the Office of Regulatory Affairs at the Rockville headquarters and also worked for the Associate Commissioner for Public Affairs. She has experience as a FDA investigator who worked in the Atlanta District Office and the New York District office for over 9 years where she gained considerable experience in the food, drug and device areas, specializing in drugs. Ms. Collins holds a B.S. degree in Chemistry from South Carolina State University, worked on a M.S. Degree in Governmental Administration at the University of Georgia and holds an M.S. Degree in Divinity from Howard University, Washington, D.C.

 

Jeffrey Shapiro
Mr. Shapiro is one of the directors at Hyman, Phelps & MCnamara Law firm in Washington, D.C. Mr. Shapiro has represented health care companies on FDA-related matters since 1994. He advises companies on a wide variety of issues in the areas of medical devices, combination products, and human tissue products, including product approvals, marketing, clinical studies, jurisdictional issues, and enforcement. Mr. Shapiro can be reached at [email protected].

 

The purchase is $595 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.25 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.