Program Overview

The Professional Science Certificate in Regulatory Affairs for militiary personnel takes advantage of your background, skills, and experience in science and technology and expands your career options in high-demand positions. The certificate prepares individual for Life Sciences industry jobs in such fields as Biotechnology, Medical Devices & Diagnostics, and Pharmaceuticals.

The program consists of four 3-unit courses and is designed to be completely online. 24/7 availability makes it easy for you to participate from anywhere in the world.

These programs are eligible for military educational benefits, tuition assistance, and other sources of financial aid. Contact Robert Turner at rturner@mail.sdsu.edu for additional information.

More information about CSU Professional Science and Technology Graduate Programs for Veterans and Active Duty Military, including admissions requirements, can be found at http://www.ces.sdsu.edu/military/.

Certificate Courses

The following courses make up the Professional Science Certificate in Regulatory Affairs.

RA 601 - THE PHARMACEUTICAL, BIOTECHNOLOGY AND MEDICAL DEVICE INDUSTRIES (3)
Pharmaceutical, biotechnology and medical device industries. Company organization and product development and commercialization associated activities, e.g., drug discovery, chemical synthesis, quality assurance, regulatory affairs, manufacturing, control and marketing.

RA 781 - PRACTICAL ETHICS FOR HEALTHCARE PROFESSIONALS (3)
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.

RA 602 – INTRODUCTION TO FOOD AND DRUG LAW (3)
Laws governing drug, biological, and medial device products. Discussion of Federal Food, Drug & Cosmetic Act, U.S. Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments.

RA 770 – CURRENT GOOD MANUFACTURING PRACTICE - GENERAL CONCEPTS (3)
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.

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.