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BMS 546 Good Manufacturing Practice

Prerequisite: Open to students with a declared concentration in Regulatory Compliance, or permission of the instructor. (Second semester/3 credits)  

This course will provide students with an in-depth review of current good manufacturing practice regulations promulgated by the Food and Drug Administration (FDA) in their regulation of the drug and device industries. Recent FDA regulatory compliance experience regarding the application of the GMP regulations, including areas where industry has failed to correctly apply or interpret current GMPs will also be examined.