TANKSLEY CONSULTING GROUP - Key Persons
Sarah Tanksley has over 15 years of laboratory and regulatory experience with both the NIH and FDA. She is an expert on a wide range of issues related to the FDA's regulatory requirements.
Experience
5 years as a Principal Consultant of Strategic Compliance with PAREXEL Consulting
4 years as a reviewer/inspector with the Office of Compliance, Center for Biologics Evaluation and Research, FDA.
7 years of research lab experience within the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the U.S. Military.
3 years as an adjunct professor in the Graduate Biochemistry and Molecular Biology Program at Georgetown University School of Medicine, teaching courses in cGMP Compliance and Regulatory Affairs.
Expertise
Warning letter and consent decree remediation
Data integrity remediation
Mock inspections
21 CFR 211
Deviation and laboratory investigations
Education
MS Regulatory Science, Johns Hopkins University
MS Biochemistry and Molecular Biology, Georgetown University School of Medicine
BS Biology, The College of William and Mary