U.S. FDA Quality System Requirements for Medical Devices: FDA Inspections - Is Your Quality Management System Ready?

This one-day seminar will address the U.S. FDA Quality System regulation with emphasis on FDA’s current focus. The U.S. FDA requirements will be presented to compare and contrast with ISO13485 and ISO14971 Risk Management. Actual FDA Warning Letter examples will be used to illustrate key points. In addition, the FDA inspection process will be explained with advice on how to prepare your company to respond to 483s and Warning Letters.