Tamara Ely

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FDA
Senior Policy Advisor
Tamara Ely holds a bachelor’s degree in Chemistry from West Virginia University and a master’s degree in Quality Assurance and Regulatory Affairs from Temple University’s School of Pharmacy. Since 2015, she continues to support the School of Pharmacy as an adjunct associate professor teaching Current Good Manufacturing Practices and periodically co-instructs a course on Microbiological Concepts in Pharmaceuticals.

Since 2010, Ms. Ely has worked as a Senior Policy Advisor in the Office of Manufacturing Quality in the Center for Drug Evaluation and Research (CDER) reviewing administrative and regulatory actions regarding drug adulteration, evaluating inspectional findings, and determining the acceptability of manufacturing facilities. In this role, she also participates in the development of science-based regulatory policy and guidance. In the numerous undisclosed years prior to her joining CDER, she held various quality and compliance positions within the pharmaceutical industry: analytical chemist, certified quality auditor, compliance reviewer, CGMP consultant, and validation consultant.