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Apr 25, 2024
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BTEC 6302 - Intro to Regulatory AffairsCredit Hours: 3.0 Lecture Contact Hours: 3 Lab Contact Hours: 0 Prerequisite: Graduate standing and consent of instructor.
Overview of federal and global regulations of biotechnology products. Topics include: history, regulatory agencies, drugs, biologics, and medical device submissions, GLP, GCP, GMP, and FDA inspections.
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