Master of Science in Biomedical Quality Systems

This degree program provides a comprehensive background in quality systems principles and practices for the development, testing and manufacture of pharmaceutical, biopharmaceutical and medical device products with the additional training necessary for compliance with regulatory requirements.

The degree offering focuses on principles of quality control and quality assurance that support compliance with the laws and regulations imposed by the Federal government, especially the Food and Drug Administration, related to drug discovery, development, testing, and manufacture of products for commercial distribution. The degree program will provide students with detailed knowledge and understanding of current practices and regulations and their practical application to the development and commercialization of drug, biologics, and medical device products. Also incorporated into the degree program are business courses that provide students with communication and management skills essential for the successful QA/QC professional in an industry work environment.

Understanding of industry specific quality assurance and control requirements must be integrated with knowledge of applicable federal laws and regulations pertaining to the testing of biomedical products. Consequently, a large proportion of program instructors are industry professionals with relevant experience in the biomedical industries.

Certificate In Biomedical Quality Systems

Students interested in earning the Certificate in Biomedical Quality Systems need to apply for admission to the University for this program through CSU Mentor and will be required to submit official transcripts showing completion of a bachelor's degree.  Please select "Certificate: Biomedical Quality Systems" when submitting your application.

While you may register for your first course of the program prior to being formally accepted into the University, you will not be a candidate for the Certificate until you have been accepted into the University.  You must complete the application process while enrolled in your first course.  If you are a student currently taking courses towards the Certificate and you have not completed an application through CSU Mentor, please contact Dr. Dale Sevier at dsevier@sciences.sdsu.edu.

Students may earn the Certificate in Biomedical Quality Systems by successfully completing the certificate courses. Other courses may not be substituted. You must earn a “B” or better in all Certificate courses. You can register for these courses by calling the SDSU College of Extended Studies (CES) at 619-594-5152 or by visiting http://www.ces.sdsu.edu/regulatoryaffairs.html and clicking on “register for classes”.