CDRH’s Office of Compliance Reorganization Rebroadcast

Webinar Rebroadcast

CDRH’s Office of Compliance Reorganization

Your office, April 10, 2014

 

Meet your instructors
 

Steve Silverman is the Director of CDRH’s Office of Compliance. In this role, he oversees a staff of more than 170 scientific and regulatory personnel who assure compliance with the medical-device related provisions of the federal Food, Drug, and Cosmetic Act and its implementing regulations. Mr. Silverman also represents CDRH on an agency-wide globalization initiative, and leads a Center-wide compliance strategic planning effort.

Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act. Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs.