Karen A. Coleman
National Expert in Medical Devices, U.S. Food and Drug Administration

Karen has worked for FDA since 1977.   She is a National Expert in Medical Devices, a Level II Certified Investigator, a Performance Auditor, and a member of the Device Certification Board.  She conducts inspections of medical device manufacturers in the USA and around the world.  She is an instructor for FDA national training courses on Industrial Sterilization of Drugs and Medical Devices, Process Validation, Basic Medical Devices, and the Orientation to International Inspections.   She provides on the job training to other investigators.  She speaks to industry groups providing information on FDA Policy for medical devices, Quality System Regulations, sterile packaging, and process validation.  She holds memberships in American Society for Quality, Regulatory Affairs Professionals Society, AMS International, and American Association of Family and Consumer Sciences.