3 units
- Required Courses
Offered: Summer 2027 (not offered), Spring 2027 (unknown), Fall 2026 (unknown)
Counts toward
- Regulatory Affairs Advanced Certificate (2026-27) - Required Courses
- Regulatory Affairs Advanced Certificate (2025-26) - Required Courses
- Regulatory Affairs Advanced Certificate (2024-25) - Required Courses
- Regulatory Affairs, M.S. (2026-27) - Required Courses
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- Regulatory Affairs, M.S. (2025-26) - Required Courses
- Regulatory Affairs, M.S. (2024-25) - Required Courses
Interpretation and application of current Good Manufacturing Practices (GMPs) to drug substance and drug product manufacture. Differentiation between full and appropriate GMPs required for clinical supplies production and commercial manufacturing. Variances between FDA and European Union requirements for the control and manufacture of pharmaceuticals. Aseptic regulatory inspections processing and preparation.
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 770 is not offered in Spring 2027. Check all R A classes for other terms.