Why Are cGMPs So Important?

Why Are cGMPs So Important?
  • Item #: 2013001

Why Are cGMPs So Important? is a program that explains 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.

Objectives: 

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

  1. Recognize and recall three major tragedies that resulted in the establishment of GMP regulations.
  2. Describe what is meant by cGMP.
  3. List the controls cGMPs regulate.
  4. Explain why following cGMPs are so important.
  5. List the ways in which the FDA determines if a company is following cGMPs. 
  6. Describe how the FDA protects the public when there are cGMP violations.

 Topics: 

      I.   Introduction

      II.   Program Objectives

      III.  Three Major Tragedies

      IV. What are GMPs? 

      V.   What are cGMPs?

      VI.   What do cGMPs regulate?

      IX. What happens if a manufacturer is not following cGMPs, are drug products safe for use?

      X.  What can FDA do to protect the public when there are cGMP violations? 

DVD:  Running time: 15 minutes

Program package includes:

  • Leader's Guide
  • Interview Issues Worksheet and Answer Key
  • Assessment and Answer Key

 

Click on the Forward Arrow below to see a preview of this program.  See License Type below for details.

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Price $595.00