Change Control is arguably the most critical quality system for safeguarding patient safety and product quality. Although specific steps vary from firm to firm, there are a few standard elements and best practices that are essential for a robust, sustainable change control programme. Many firms struggle to complete change controls in a timely manner and spend incalculable time, effort and rework trying to keep up. This course provides a simple, high-level process, along with best practices and techniques, for sticking to it in a timely manner while maintaining compliance and providing safe, effective products for patients.
The course includes key definitions, regulatory requirements, importance and basic change control process overview, including key roles and responsibilities. It also provides specific do’s and don’ts for all key roles and steps in the change control process, including requesting changes, assessing risk and classifying changes, action planning and coordination, assessing impact, designing effectiveness checks, and writing results and justifying conclusions. It also includes how to manage change controls and write clear, logical reports that withstand regulatory scrutiny.
This interactive course includes audience questions and polling, activities and exercises to help participants apply and retain the knowledge.
Who Should Attend
This comprehensive 15-hour course will be valuable to all personnel involved in the change control process in any GMP environment, including Manufacturing, Quality, Supply Chain, and Facilities and Engineering employees. It will benefit individual contributors, subject matter experts, area managers and QA personnel who author, coordinate, contribute to, assess risk for and/or approve change controls.