3 units
- Electives
Offered: Summer 2027 (not offered), Spring 2027 (unknown), Fall 2026 (unknown)
Counts toward
- Regulatory Affairs, M.S. (2026-27) - Electives
- Regulatory Affairs, M.S. (2025-26) - Electives
- Regulatory Affairs, M.S. (2024-25) - Electives
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.