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Apr 15, 2026
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BIOTEC 565 - Introduction to cGMP and QSR Compliance
Prerequisites: BS in a STEM field, Certificate in Biotechnology
Requirement Fulfillment: Fulfills a 3 credit course requirement for the 4+1 MA in Biotechnology
Delivery: Lecture
The development, manufacturing, and post-marketing management of medical products are regulated by clearly defined and rigorously enforced requirements. Regulations include requirements for product development and design control, manufacturing and control of clinical trial samples, scale-up from laboratory scale to full manufacturing, post-market surveillance and reporting, and field actions.
3 credits
Fall
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