Regulation of Drug Manufacturing: An Introduction

Examine Current Good Manufacturing Practices (cGMPs) for drugs and define “adulteration” and “misbranding”. Review the different types of inspections, including the differences between foreign and domestic inspections. Explore the elements of a 483 observation and the components involved in closing out an inspection.

Lindsay P. Holmes, Associate, BakerHostetler

This session was recorded as part of FDLI’s Virtual Introduction to Drug Law and Regulation Course in April 2021. 

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