REGULATORY AFFAIRS
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>> Master of Science in
Regulatory Affairs
>> Advanced Certificate in Regulatory Affairs |
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 Online
Master of Science in Regulatory Affairs |
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Offered by SDSUs College of Extended Studies and The Center
for Bio/Pharmaceutical and Biodevice Development (CBBD).
CBBD concentrates on the creation and implementation of innovative university curricula
and training programs that respond to, and promote the continued development and growth
of the pharmaceutical, biotechnology, and biodevice industries.
The degree focuses on laws and regulations mandated by the Federal government, especially
the Food and Drug Administration, related to discovery, development, testing, and manufacture
of products for commercial distribution, and post-marketing surveillance. The degree program
will provide students with detailed knowledge and understanding of current regulations and
their practical application to the development and commercialization of drugs, biologics,
and medical device products.
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Courses usually are taught online to provide the flexibility necessary for the student's
other professional and personal commitments. Students are normally enrolled in no more than
two online courses at a time.
Please note: Registrations after the first day of class and for 799A require department
approval. For approval call (619) 594-6030.
If you have completed the Advanced Certificate in Regulatory Affairs
and you plan to continue with the Master of Science in Regulatory Affairs, you must apply
and be accepted to SDSU before taking any more courses. You may not take more than 12 units
prior to being officially accepted into the SDSU MA program. For more information, please
contact the Division of Graduate Affairs at gra@mail.sdsu.edu
or call (619) 594-5213.
For more information call (619) 594-6030 or see www.cbbd.sdsu.edu
>> View All Online Courses
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 Online
Advanced Certificate in Regulatory Affairs |
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The certificate involves the completion of four required courses, RA 601, RA 602, RA
770, and RA 781. RA 601 covers the various steps in the development process for
pharmaceuticals, biologics, and medical devices, with an understanding of the regulatory
impact on this process. RA 602 provides a basic knowledge of the laws and regulations
governing these industries. RA 770 covers the basic concepts of good manufacturing
practices. RA 781 covers the ethical issues confronting health care professionals.
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Please note: Registrations after the first day of class and for 799A require department
approval. For approval call (619) 594-6030.
For more information call (619) 594-6030 or see www.cbbd.sdsu.edu
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RA 705 - Project Planning for the Biomedical Industries |
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Complexity of biomedical product development. Projects and strategies for effectively planning and managing them. Understanding and utilization of management and planning strategies as applied to these biomedical product development projects. Strategies for planning, scheduling, and effective management of regulatory affairs activities and related tasks associated with development of a biomedical product.
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Instructors: Russell Saunders, Ph.D., biomedical project planning consultant. Wade Stone, PMP, project planning consultant.
Special Sessions
Credit Course No. RA 705 (three units)
Schedule No. 08SU 77781 EK
Dates:
May 26-August 3 (Registration deadline: May 26)
Location: Online
Fee:
$1,551
Register online for 08SU 77781 EK
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RA 772 - Post Approval Activities, Including FDA Advertising, Promotion & Labeling |
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FDA and FTC rules and regulations governing advertising, promotion, and labeling for prescription drugs, biologics, medical devices, and over-the-counter drugs.
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Instructor: Larry E. Gundersen, Ph.D., director, Regulatory Affairs Program.
Special Sessions
Credit Course No. RA 772 (three units)
Schedule No. 08SU 77792 EK
Dates:
May 26-August 3 (Registration deadline: May 26)
Location: Online
Fee:
$1,551
Register online for 08SU 77792 EK
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RA 773 - Medical Device Regulations |
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Overview of laws and FDA regulations for medical devices, in vitro diagnostics, radiological devices, FDA jurisdiction, registration, listing, labeling requirements, classification, Investigational Device Exemptions (IDE), pre-market approval (PMA), and pre-market notification [510(k)].
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Instructor: Alan Donald, M.S., MBA, RAC.
Special Sessions
Credit Course No. RA 773 (three units)
Schedule No. 08SU 77803 EK
Dates:
May 26-August 3 (Registration deadline: May 26)
Location: Online
Fee:
$1,551
Register online for 08SU 77803 EK
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RA 776 - Validation Aspects |
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Broad coverage of all aspects of validation in the pharmaceutical, biologic, and medical device industries.
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Instructor: David Vincent
Special Sessions
Credit Course No. RA 776 (three units)
Schedule No. 08SU 09111 EK
Dates:
August 4-Oct. 12 (Registration deadline: August 4)
Location: Online
Fee:
$1,551
Register online for 08SU 09111 EK
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RA 778 - QC & QA in the Bioscience Industry |
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Review of requirements, procedures, controls, and documentation for quality control and assurance in the manufacture and commercial distribution of drugs, biologics, and medical devices.
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Instructor: K.A. Ajit Simh, M.S., president, Shiba Associates.
Special Sessions
Credit Course No. RA 778 (three units)
Schedule No. 08SU 09122 EK
Dates:
August 4-Oct. 12 (Registration deadline: August 4)
Location: Online
Fee:
$1,551
Register online for 08SU 09122 EK
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RA
799A - Thesis or Project
Preparation of thesis or project for the master's degree.
Instructor: Joyce Williams, MBA, president, ProFocus Regulatory Solutions.
Special Sessions Credit Course No. RA 799A (three units)
Dates: May 25-August 20 (Registration deadline: May 25)
Location: Online
Fee: $1,551 |
Contact the Division of Graduate
Affairs at (619) 594-5213 for approval to enroll and to obtain the schedule number
for RA 799A. |
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The statements found on this page/site are for informational purposes only.
While every effort is made to ensure that this information is up-to-date
and accurate, official information can be found in the University publications.
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