Regulation of Drug Manufacturing: An Introduction
Learn Current Good Manufacturing Practices (cGMPs) for drugs and be able to define “adulteration” and “misbranding”. Understand the different types of inspections, including the differences between foreign and domestic inspections. Recognize the elements of a 483 observation and the components involved in closing out an inspection.
Paula R. Katz, Of Counsel, Covington & Burling LLP
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2023.