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Pharmaceuticals, Medical Devices

Change Control

About the Course

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 eLearning course presents the concept of change control by placing the learner in the role of a change control manager. Training topics include key steps, change indicators, and notification of governing bodies. After completing this online learning 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.