Kenneth F. Miles, Ph.D., RAC, is a seasoned professional in Quality, Regulatory and Clinical Affairs and has worked with food, drugs, blood/biologics, medical devices, dietary supplements, cosmetics and tobacco products. He has worked in senior quality and regulatory roles in the medical products industry for more than 25 years. Dr. Miles has worked for a number of large and small pharmaceutical, biotech, dietary supplements and medical device companies. Interfaced with FDA at Local, District and Center levels, and has dealt with several foreign ministries to bring companies into compliance. Set up regulatory and quality systems for countries around the world, including the Pacific Rim,