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Why Are cGMPs So Important?

Why Are cGMPs So Important? is a program that explains some of the key events leading up to the development of the GMPs and then goes on to explain what the cGMPs are and why they are so important.

Program Objectives
At the end of this program, participants will be able to:

  • Recognize and recall three major tragedies that resulted in the establishment of GMP regulations.
  • Describe what is meant by cGMP.
  • List the controls cGMPs regulate.
  • Explain why following cGMPs are so important.
  • List the ways in which the FDA determines if a company is following cGMPs.
  • Describe how the FDA protects the public when there are cGMP violations.
Topics
  • Introduction
  • Program Objectives
  • What are GMPs?
  • What do cGMPs regulate?
  • What happens if a manufacturer is not following cGMPs, are drug products safe for use?
  • What can FDA do to protect the public when there are cGMP violations?
  • DVD Runtime: 15 Minutes
  • Extras
  • Leader's Guide
  • Assessment and Answer Key
This program is shipped directly from the US producer.