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MBT 520. Biotechnology Product Development: Concepts, Practice and Regulatory Issues. 2 hours.

Product development and commercialization processes. Product life cycles, program management basics. Intellectual property. Regulatory affairs issues: GLP, product registration, GMP, documentation, validation, FDA inspections. Course Information: Prerequisite(s): Graduate standing in Medical Biotechnology program or approval of the Department of Biomedical Sciences at College of Medicine - Rockford.