FDA Regulation and Compliance Expert Witness
FDA Regulation and Compliance | E-065690
Expert Qualifications
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.
Bio Snapshot
Location: CO
B.S., Environmental Chemistry, State University of New York at Purchase
M. S., Environmental Science, University of Colorado Denver
Member, Regulatory Affairs Professionals Society
Recipient, Compliance Officer of the Year Award, FDA
Former, Chemist, Food and Drug Administration
Former, Compliance Officer, Food and Drug Administration
Former, Supervisory Consumer Safety Officer, Food and Drug Administration
Former, Compliance Officer, Food and Drug Administration
Former, Senior Case Review Expert, Food and Drug Administration
Current, Principal/Owner, a Private Consulting LLC
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