Medical Product Quality Graduate Certificate

The graduate certificate in Medical Product Quality is a 12-unit program designed for students with a background in biological, pharmaceutical and biomedical sciences and biomedical engineering. Quality assurance and quality control are the two functions in the biomedical industry that are responsible for the testing and oversight required  to ensure the safety of the health care products that are manufactured. An essential tenet of regulatory oversight is the assurance of quality through guidelines, audits and inspections. In this program the regulations and guidelines to ensure the quality of drugs, biologics and medical devices, both in the United States and internationally, will be studied to develop an understanding of the basic principles important for the interpretation and implementation of quality practices and quality systems. Course work is typically delivered in nontraditional formats such as intensive weekend sessions and will use distance learning tools, Webcast lectures and study materials. Courses can be taken on site, by distance or as a blended combination. Students should confirm their specific course work plan in consultation with the graduate advisers before beginning the program. Students who have bachelor’s degrees from accredited colleges or universities must submit an application for graduate study through the regulatory science program of the School of Pharmacy. GRE scores are not required for admission to the certificate program. Students are expected to enroll each semester until the program is completed.

Students must complete 12 units of specified course work (four course minimum), that normally will include an introductory course in the basic principles of quality systems, a course in project management, a course in quality tools and one elective chosen from the quality or regulatory offerings. The certificate can be completed on a part-time basis but must be finished within five years.