Change Control

The control of change is very important in the regulated industries of drug products, biologics, and medical devices. Changes to processes, material, equipment, and people can have a direct impact on the quality, effectiveness, and safety of the product. This course presents the concept of change control by placing the learner in the role of a change control manager. Topics include key steps, change indicators, and notification of governing bodies. After completing this course, you will be able to identify what a change control consists of and recognize the basics of the change control model. You will also be able to recognize the importance of a change control. Lastly, you will be able to recognize the key elements of an effective change control system.

After this course learners will be able to identify what a change control consists of and recognize the basics of the change control model. recognize the importance of a change control. recognize the key elements of an effective change control system.