James has 17 years of experience working in FDA regulated cGMP Quality Assurance / Control field. In his career he has worked directly with regulated human and veterinary drug product and compounded product, medical device, packaging, and food industries.  James has direct experience in hosting FDA general / pre-approval inspections, as well as client and supplier audits. He specializes in evaluating, implementing, and restructuring quality systems such as OOS, investigation, quality agreements, and CAPA. James holds a Bachelor’s degree in Microbiology and a Master’s degree in Business Administration. Quality is one of James’ passions.