One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes did not adversely impact products, processes, equipment, facilities, etc. A single inadequate change may lead to significant negative events, including the release of the sub-standard product or product recall. A pattern of inadequate changes may require costly and time-consuming system remediation efforts.

It is therefore critically important to assure that changes are properly described, justified, assessed for risk, implemented, and documented. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval.

This seminar will help all personnel involved in proposing, assessing, and implementing changes to understand and successfully apply Change Control best practices. A key focus will be placed on change proposals, justification/risk assessment, and change execution/implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed. Techniques for assuring robust Change Control programs in light of COVID-19 restrictions will also be discussed.

This is a practical how-to course, designed to provide participants with skills they can immediately apply to change controls within their own organizations. Case studies will allow participants to practice skill sets in cooperation with the instructor.

Learning Objectives:

Upon completing this course, participants should be able to:

• Understand the purpose of change control
• Understand regulatory requirements and FDA expectations for change control
• Identify what types of changes are /are not subject to change control
• Properly describe changes
• Properly justify changes
• Develop a comprehensive Change Execution Plan
• Conduct a proper change Risk Assessment
• Ensure proper execution of changes
• Ensure proper implementation of changes
• Develop a complete Change Control documentation package
• Utilize critical thinking skills throughout the change control process
• Avoid pitfalls during the change control process