By the end of the course you will be able to:
鈥nderstand the regulatory background to FI and CAPA
鈥nderstand risk analysis
鈥nderstand the use of FI in both prospective and reactive situations
鈥nderstand tools and techniques that can be used in FI to identify probable root cause
鈥nderstand the requirements of a CAPA system for effective implementation of actions
鈥ppreciate the importance of documenting the process used
鈥dentify 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.
鈥nderstand the regulatory background to FI and CAPA
鈥nderstand risk analysis
鈥nderstand the use of FI in both prospective and reactive situations
鈥nderstand tools and techniques that can be used in FI to identify probable root cause
鈥nderstand the requirements of a CAPA system for effective implementation of actions
鈥ppreciate the importance of documenting the process used
鈥dentify 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.
