Biomedical Quality Systems *Discontinued*

Certificate Program

The California State University, East Bay Advanced Certificate in Biomedical Quality Systems meets the needs of science managers who require a thorough knowledge of quality control and quality assurance principles and practices as they apply to the development, testing and manufacture of pharmaceutical, biopharmaceutical and medical device products.

Offered in collaboration with San Diego State University's Center for Bio/Pharmaceutical and Biodevice Development, the program's online-only format makes it convenient for busy professionals anywhere in the world, not just those who live or work in the San Francisco East Bay Area. As a critical part of their training, students will acquire an in-depth knowledge of the federal laws and regulations that govern drug and medical device development, testing and manufacturing, especially those of the Food and Drug Administration (FDA).

Program Objectives

• To provide graduates an understanding of current quality systems practices and regulations and their practical application to the development and commercialization of drug, biologic and medical device products.
• To give graduates the knowledge necessary to improve their organization's efficiency and effectiveness in the areas of quality control and quality assurance.
• To give graduates the educational foundation that will help them advance in their careers.

Who Should Attend

• Science managers who seek a stronger and up-to-date knowledge of quality systems practices and regulations and their practical application to the development and commercialization of drug, biologic and medical device products.
• Science managers who are or expect to be responsible for process and product development, validation issues, quality systems and process improvements.

Program Highlights