Biochemical Regulatory Engineering, P.B.C.

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The certifcate provides a comprehensive exposure to the issues related to obtaining and maintaining regulatory agency approval (such as, from the Food and Drug Administration) for biopharmaceutical products.

Course Requirements

This graduate certificate includes completion of 12 credits by taking the sequence of four courses:

ENCH 660 - Regulatory Issues in Biotechnology [3]
ENCH 662 - Good Manufacturing Practices for Bioprocesses [3]
ENCH 664 - Quality Control and Quality Assurance for Biotechnology Products [3]
ENCH 666 - Biotechnology GMP Facility Design, Construction and Validation [3]