cGMP Essentials: Change Control

In this online interactive course, we’ll be looking at change control. We’re going to discuss why we need change control and what that process looks like. You’ll see what areas are typically governed by change control. We’re also going to look at the considerations you should have regarding how the change will impact the system, how you’re going to implement the change, and follow the proper notification procedure.

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Course Details

Learning Objectives

By the end of this course, you will be able to:
  • Discuss the importance of change control and its role in the pharmaceutical industry
  • Identify areas that are governed by change control
  • Recall key components of the change control process
  • List the regulatory requirements for making the change

Specs

Course Level Fundamental
Languages English
Compatibility Audio, Video, MobileReady

Charles "Chuck" Walker

Chuck currently holds the position of Director, Regulatory Compliance at Cambrex Charles City, Inc. (CCC).He is responsible for the overall management and leadership of Quality Assurance and Environmental, Health, Safety and Security. Prior to joining CCC, Chuck worked in Quality Assurance at Novartis Consumer Health (Lincoln, NE), where he was responsible for implementing, maintaining and supporting quality initiatives for Novartis Consumer Health. Chuck received his B.A. in Health and Physical Education from Hillsdale College.

Course Applies To

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