Practical Aspects of Regulatory Compliance

Uses a series of practical exercises and discussions designed to offer students an opportunity to develop the ability to translate regulatory requirements for medicinal products into practical documents and broadly applicable research solutions. Topics include how to create practical documents based on regulations and guidelines; complete production batch records; conduct product testing and perform inspections; and, in general, figure out what CGMP, GLP, and GCP requirements really are. Each session involves homework that requires students to research applicable regulatory and industry information, as well as activities designed to aid in the comprehension of the regulations and in the review of real-life industry issues. Prereq. (a) RGA 6100, RGA 6201, and RGA 6203 or (b) RGA 6202.

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