Advanced Certificate in Regulatory Affairs

The Advanced Certificate in Regulatory Affairs is a four-course subset of the Masters Degree Program that provides foundational knowledge in the regulatory field. All four courses are transferable to the Masters Degree.

You may register for your first course of the program prior to being formally accepted into the University. Since only one 3-unit course can be transferred into the Certificate Program, you must be accepted to the University before you take additional courses. Also, you must have completed a baccalaureate degree before enrolling in a course that you wish to transfer into the Certificate Program.

Students may earn the Advanced Certificate in Regulatory Affairs by completing the certificate courses, earning a “B” or better in each course.

Four courses are required for the Advanced Certificate in Regulatory Affairs:

RA 601: Pharmaceutical, Biotechnology, and Medical Device Industries (3 units)

Introduction to the pharmaceutical, biotechnology and medical device industries. General overview of company organization and product development and commercialization associated activities, e.g., drug discovery, chemical synthesis, quality assurance, regulatory affairs, manufacturing, control and marketing.
RA 602: Food and Drug Law (3 units)

Prerequisite: Regulatory Affairs 602
Introduction to laws governing drug, biological and medical device products. Discussion of Federal Food, Drug & Cosmetic Act, US Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments.
RA 770: Current Good Manufacturing Practices - General Concepts (3 units)

Prerequisite: Regulatory Affairs 602
Study of current Good Manufacturing Practice regulations to assure quality of marketed products. Application to manufacturer’s organization, personnel, facilities, equipment, control systems, production, process controls, laboratory procedures and records.
RA 781: Ethics for Life Science Professionals (3 units)

Prerequisite: Regulatory Affairs 602
Ethical issues confronting regulatory affairs professionals. Evaluate, defend, and discuss moral positions concerning impact on laboratory animals, human subjects, patients, and consumers. Develop capacities to generalize, translate, and apply principles and ideas to modern biomedical practice. Topics include the treatment of animals, trial design, informed consent, the operation of institutional review boards, international clinical trials, clinical trials and vulnerable populations, and whistle blowing.

To apply, see Admissions page. For more information, call 619-594-6030.

Link to Required Federal Gainful Employment Disclosures