How to Implement Change Control: Best Practices for Operational Excellence and FDA Compliance

FDA Warning Letters and recent high profile recalls indicate insufficient, poor or even lack of meaningful change control as a common cGMP deficiency. The traditional paper-based, manual and ad-hoc approach to change control and management is error prone, unreliable and ultimately unsustainable. An enterprise-wide change management solution is critical for operational excellence as well as for regulatory compliance.

In this webinar, we will review common bottlenecks and issues related to change control and how to implement industry best practices by leveraging a paper-less and workflow-based system.

Key topics that will be covered include:

• Defining and implementing standard change management and control process across the enterprise
• Following a structured methodology for each change request and tracking it through its lifecycle from initiation through verification to closure
• Identifying the impact and risk of changes on the business to avoid unintended outcomes
• Improving coordination in change execution across departments while centrally tracking changes to avoid errors and redundancies