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.