Yuexia Li

Yuexia Li

Yuexia Li

Vice President, Technical

Yuexia has the in-depth knowledge in cGMP compliance and the FDA inspection findings. She is also very familiar with the FDA generic drug review process and associated details on the generic drug user fee program (GDUFA). Yuexia is very knowledgeable in quality management system (QMS) and ISO 9000/9001 related matters.

Most recently, as the Deputy Director of the Office of Program and Regulatory Operations (OPRO) in the Office of Compliance (OC), she was leading the implementation of QMS, especially for process improvement and efficiency enhancement relating to warning letter issuing, recall process, and varies of enforcement actions issued by the Office Compliance in CDER. By participating in many regulatory meetings, she had observed many common problems and issues the Agency had related to cGMP compliance.

Also, as the generic backlog reduction lead for the Office of Pharmaceutical Quality (OPQ) in CDER, she had observed what the applicant can do to avoid non-necessary delay for the generic drug application (ANDA) approval. Yuexia was the very first QMS staff hired by the Office of Generic Drugs in CDER/ FDA, she was personally involved with many review process mapping and improvement projects, especially related to the CMC section. While serving as the Associate Director for Regulatory Affairs for the Office of Lifecycle Drug Products (OLDP), OPQ/ CDER, she was involved with many generic CMC review process improvement projects.

Work Experience

Prior to FDA, Yuexia was the senior director of QMS for a medical device company, under her leadership, the company obtained the 510k market clearance for the detection of Anthrax, the first one in the US and hosted FDA, USDA, and DHS (Department of Homeland Security) inspections. Thus, she is very familiar with QSR, 21 CFR, part 820 for medical devices, especially for in vitro diagnostics devices.

Education

Yuexia has a Ph.D. in Molecular biology/virology from University of Alabama, a Master’s degree from the Institute of Zoology, Chinese Academy of Sciences, a Bachelor’s degree from University of Science and Technology of China. She is a Certified Manager of Quality/Organizational Excellence( ASQ).

We are always available for a conversation.

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