By the end of the course you will be able to:
•Understand the regulatory background to FI and CAPA
•Understand risk analysis
•Understand the use of FI in both prospective and reactive situations
•Understand tools and techniques that can be used in FI to identify probable root cause
•Understand the requirements of a CAPA system for effective implementation of actions
•Appreciate the importance of documenting the process used
•Identify company policy and procedure required to meet regulatory requirements
Who should attend:
The course is suitable for personnel involved in risk assessment, failure investigation, root cause analysis and CAPA management at policy maker or practitioner levels in the organisation.
•Understand the regulatory background to FI and CAPA
•Understand risk analysis
•Understand the use of FI in both prospective and reactive situations
•Understand tools and techniques that can be used in FI to identify probable root cause
•Understand the requirements of a CAPA system for effective implementation of actions
•Appreciate the importance of documenting the process used
•Identify company policy and procedure required to meet regulatory requirements
Who should attend:
The course is suitable for personnel involved in risk assessment, failure investigation, root cause analysis and CAPA management at policy maker or practitioner levels in the organisation.
