Life sciences companies that wish to avoid FDA enforcement actions must be able to respond effectively to FDA-483s and Warning Letters. This webinar will discuss some of the common mistakes that companies make when submitting responses to the FDA and strategies for avoiding Warning Letters altogether.

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 FDA. He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Mr. Niedelman retired from the FDA 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. He ensured consistent interpretation of the FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. Additionally, Mr. Niedelman assisted in the day-to-day management of the FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. Before joining the Office of Enforcement, Mr. Niedelman spent nearly 24 years throughout the Office of Compliance at the Center for Devices and Radiological Health (CDRH) in a number of management positions. During those nearly 24 years at CDRH he was responsible for implementing many of the newly created statutory requirements and drafting and shaping many of the regulations and policies affecting the sale, distribution and promotion of medical devices.