Karen Coleman

Karen Coleman

Senior Compliance Expert, Medical Devices, IHL Consulting Group

Karen retired after 30 years with FDA, the last 15 of which she was a Medical Device National Expert.  Karen served as FDA Certified Device Investigator and a Medical Device Performance Auditor.  She conducted cGMP and Pre-Market inspections both domestically and internationally involving complex devices, sterile devices, tissue devices, diagnostics, and radiological equipment.  She served as a principal FDA instructor in the agency for FDA Quality Systems training courses and Industrial Sterilization.  She was an instrumental FDA representative on the Global Harmonization Task Force (GHTF), Study Group 4 on Auditing.  She received special agency recognition at the highest levels including the Commissioner’s Special Citations, Commendable Service Awards, and Outstanding Service Awards.  Karen holds a Bachelor of Science degree from the University of Montevallo and a Master of Science degree from Auburn University.