Effective CAPAs: How to Avoid Scrutiny in FDA’s Latest Area of Focus

Why Should You Attend:

The most important area audited by the FDA is CAPA. FDA views this system as an indicator for the overall effectiveness of the firm’s Quality Management System. In recent years, CAPA has been an increasingly common finding on FDA 483 forms.

Attending this course will enable you understand FDA’s expectations regarding CAPA effectiveness, learn to demonstrate that Corrective Actions do not adversely affect the finished device quality, and provide a road-map to demonstrate that your CAPA program verifies the effectiveness of CAPA actions.

Now is the time to assess and improve your CAPA system so that you stay ahead of FDA expectations and prevent a 483 finding that could have been avoided. This webinar will present simple but powerful tools, with real world examples how companies manage CAPA systems.

Areas Covered in the Webinar:

  • Understanding FDA’s increased focus on CAPA effectiveness
  • CAPA fundamental principles
  • How to effectively document root cause analysis
  • How to demonstrate that CAPA actions have been effective
  • What great Effectiveness Checks look like
  • Implementing a “closed loop” CAPA system that meets company needs and regulatory requirements.
  • Demonstrating that CAPA actions do not adversely affect the finished device.
  • Lessons learned and after action reviews

For Registration