This online 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 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 drugs, 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 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 professionals with relevant experience in the biomedical industries.

Please note: registrations after the first day of class and for 799A require department approval. For approval call (619) 594-6030.

For more information visit www.cbbd.sdsu.edu or call (619) 594-6030.