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R A 778 - Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices

R A 778: Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices (3 units) at San Diego State University. Not offered in Spring 2027. Prerequisites: R A 602. Counts toward Regulatory Affairs, M.S. (2026-27), Regulatory Affairs, M.S. (2025-26).

3 units
  • Electives
Offered: Summer 2027 (not offered), Spring 2027 (unknown), Fall 2026 (unknown)
Quality and compliance functions in biotechnology and pharmaceutical companies to include out-of-specification results, developing product specifications, and writing compliant process deviations. Good Laboratory Practices (GLPs). Graded approach for Active Pharmaceutical Ingredients (APIs) manufacturing. Biologics, drugs, and medical device regulations. Quality control (QC) role vs. quality assurance (QA) role. Current trends in industry.

From the catalog

Grading
LTR: Letter Graded. The class will be offered for letter grade with no option to take it for Cr/NC
Repeatable
Maximum 3 units.

0 sections in Spring 2027

R A 778 is not offered in Spring 2027. Check all R A classes for other terms.