Biomedical Quality Systems

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Administered by the Center for Regulatory Science in the College of Sciences

OFFICE: Geology/Mathematics/Computer Science 619
TELEPHONE: 619-594-6030 / FAX: 619-594-6381
E-MAIL: regsci@sdsu.edu
WEBSITE: http://regsci.sdsu.edu/

Admissions is suspended for the Biomedical Quality Systems Advanced Certificate.  

General Information

The Advanced Certificate in Biomedical Quality Systems provides critically needed knowledge in Quality Systems and Quality Management for the developing, testing, and manufacturing of pharmaceutical, biologic, in vitro diagnostic, and medical device products. This certificate focuses on quality control and quality assurance principles that support compliance with the laws and regulations imposed by the federal government, specifically the Food and Drug Administration (FDA), and international regulatory authorities related to discovery, development, testing, and manufacturing of medical products for commercial distribution. The curricula include quality system principles and practices, as well as the Lean Six Sigma methodology. Students will also be introduced to Good Manufacturing Practices (GMPs) and obtain related compliance and regulatory training. The certificate is offered by the Center for Regulatory Science in the College of Sciences, in partnership with SDSU’s Global Campus.

Faculty

Graduate Advisor: Walker, Kim, Faculty Director/Graduate Advisor, Center for Regulatory Science (B.S., Auburn University; M.S. San Diego State University)

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