Welcome to the Advanced Certificate in Regulatory Affairs. Completing this program will give you the knowledge and skills necessary to pursue your career in diverse industries such as pharmaceuticals, biotechnology, and medical device development and production.

In order to enroll in this program, you must hold a baccalaureate degree from a regionally accredited institution.

Students may earn the Advanced Certificate in Regulatory Affairs by successfully completing RA 601, 602, 770 and 781, four graduate level Regulatory Affairs courses. 

All of these courses are available in the online distance learning format. Other courses may not be substituted. You must earn a "B" or better in all Advanced Certificate courses. If you decide to enroll in the Master's program in Regulatory Affairs, all 12 units earned will transfer to the Master's degree.

RA 601 - The 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.
Dates: Fall 2009

RA 781 - Practical Ethics for Healthcare Professionals (3 units)
Ethical issues confronting healthcare professionals.  Moral positions concerning impact on laboratory animals, human subjects, patients and consumers, both on a case-specific level and as applied to the field in general. Develop capacities to generalize, translate, and apply principles and ideas to modern biomedical practice. The certificate involves the completion of four required courses.
Dates: July 6-Sept. 13

RA 602 - Introduction to Food and Drug Law (3 units)
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.
Dates: Oct. 5-Dec. 13

RA 770 - Current Good Manufacturing Practice - General Concepts (3 units)
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.
Dates: Jan. 11-March 21, 2010

Tutorial for Registered Students
Students are strongly encouraged to complete the Introduction to Healthcare Product Regulation tutorial. Information about accessing this will be provided upon registration for the program. This online tutorial is self-paced and designed to be completed over a number of weeks. It is optional, but it provides important background information that will greatly benefit students as they begin their certificate courses.

If you are planning to use your veteran education benefits to pay for this program, you must complete the Veteran Education Benefits Responsibilities form and submit per the instructions provided. If you are active duty military planning to use Tuition Assistance, please contact your Education Service Officer.

Once you complete the four courses, download the Certificate of Completion form and fax it to Regulatory Affairs (619) 594-6132. You will receive the certificate within 4-6 weeks. Additionally, you can provide the name and address of your supervisor and we will notify him/her of your achievement.

Email cbbd@sciences.sdsu.edu or call (619) 594-6030.