Change Control Overview

This 45 minute self-paced learning course provides an overview of the requirements of a change control process. The change control system provides a systematic approach to managing all GxP changes made to a product or system. The review and approval of changes prior to their implementation allows us to ensure that no unnecessary changes are made and the proposal is risk assessed to determine if there will be an impact to product safety, quality, efficacy, ultimately to ensure that the patient is not harmed by any changes made.

This course will cover:

• Purpose of Change Control
• Guidelines and the Legal Requirements
• The Continuous Improvement Cycle
• Process Overview
• Change Control Drivers
• Change Control Process Steps
• System Evaluation
• Common Issues
• Hints for Success