The Orange County (CA) Regulatory Affairs Annual Educational Conference

The theme of this conference is “Regulatory Affairs: The Business of Regulatory Affairs.”

The conference is intended to provide the Drug, Device, and Biologics industries with an opportunity to interact with FDA reviewers and compliance officers from the Centers and District Offices, as well as other industry experts. The main focus of this interactive conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive Q & A, and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues.

Steve Niedelman is speaking at this conference. The topic is "Enforcement Activities of Significance: Consent Decrees 2009 (KV Pharmaceuticals, Caraco, and CareTech) and Stories from the trenches."