RGA 6415 — Fundamentals of CMC Regulations and Methods
2 semester hoursGraduateLecture
Discusses components of Common Technical Document Module 3 and describes how regulatory affairs professionals support compliance with chemistry, manufacturing, and controls (CMC) regulation. CMC regulatory affairs professionals must use technical, analytical expertise and problem-solving abilities to ensure only quality product is distributed to patients. Coursework consists of designing and evaluating core elements of an effective CMC compliance strategy, ensuring alignment with International Conference on Harmonization guidelines, U.S. Food and Drug Administration guidance, pharmacopeia, and 21 CFR.