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.