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.