Compliance Expert Witnesses in Colorado

This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.

This expert earned his BS in health and exercise science and his MS in toxicology from Colorado State University and his MS in health services administration with a concentration in biopharmaceutical regulatory compliance and his PharmD from the University of Wyoming. He is active in his field as a member of the National Community Pharmacists Association and the American Pharmacist Association. He formerly served as a pharmacy intern and the flu clinic supervisor for the student health pharmacy at the University of Wyoming. Currently, this expert is a medical content writer for a medical consulting firm.