Corrective and Preventive Action (CAPA) Systems

(8 hour course)

Thursday (1:30 p.m. - 5:30 p.m.)

 Friday (8:30 a.m. - 12:30 p.m.)

Course Content:

• Regulatory Requirements for CAPA

  • FDA’s requirements for Corrective and Preventive Action systems

  • Why CAPA systems continue to be at the top of FDA’s enforcement list

• Elements of Effective CAPA Systems

  • Framework for a compliant CAPA system

  • Definitions of a correction, corrective action, and preventive action – and why the difference matters

• CAPA Tools

  • CAPA data sources – gathering feedback from throughout your organization

  • Recommended flow chart for CAPA data collection and closure

  • Picking the right CAPA tracking tools

• What to Look for in Failure Investigations/Root Cause Analysis

  • How to conduct a proper failure investigation to its root cause

• Trending Requirements and CAPA

  • Drug and device trending requirements – what and when to trend

  • Use of statistics to find and fix CAPA problems

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