Biomedical Quality Systems

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/

Faculty

Graduate Adviser: Dowdy, Lisa C., Associate Director, Center for Regulatory Science (B.S., University of California, Irvine; M.B.A., University of California, Irvine)

General Information

The Advanced Certificate in Biomedical Quality Systems provides critically needed knowledge on Quality Systems and Quality Management for the developing, testing, and manufacturing pharmaceutical, biopharmaceutical, 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, especially the Food and Drug Administration, and international counterparts related to drug discovery, development, testing, and manufacture of products for commercial distribution. The curricula include quality systems principles and practices, as well as the Lean Six Sigma methodology. The students will also be introduced to Good Manufacturing Practices and obtain the additional training necessary for compliance with regulatory requirements. Further, students will also learn about Quality 4.0/Industry 3.0. The certificate is offered by the Center for Regulatory Science in the College of Sciences, in partnership with SDSU Global Campus.