CAPA Corrective and Preventive Action

• Purpose of a CAPA system
• ISO standards and CAPA requirements
• Differences between corrections, corrective actions, preventive actions and 'continuous improvement'
• How risk management is used in conjunction with the CAPA system
• Various investigation tools to identify root cause(s) and actions
• CAPA plans; how to write good CAPA plans, including resources and timing of actions; and how to effectively implement CAPA plans
• Effectiveness checks and various methods to achieve effectiveness checks
• External auditor perspective on CAPA systems and compliance expectations

Programme overview

This CAPA training course is a designed to introduce the trainee to the corrective action process  & tools required to effectively manage  the CAPA process.

Who is the course for

This course is designed for Senior Management, Product Design Managers, Process Engineers, Manufacturing Cell Business Owners, Production Team Leaders QA and Regulatory personnel working on CAPA systems.

Learning outcomes

Learners will have a complete understanding of:

The CAPA system

Regulatory audit approach to CAPA

How to evaluate your own CAPA system