Tel: +44 (0)118 918 4076 E-mail: [email protected] Bookings: [email protected] Web: www.rssl.com RSSL Training The Reading Science Centre, Whiteknights Campus, Pepper Lane, Reading, Berkshire, RG6 6LA Failure Investigation and Corrective and Preventive Action Scope This course provides an introduction to the requirements of systematic failure investigation (FI) and corrective and preventive action (CAPA) practices as described in ICH Q9 and made a regulatory requirement in Europe by Annex 20 of the Guide to GMP, and in the USA by the Federal Register/FDA Guidance for Industry. The course is focused on company responsibilities within a quality risk management system, and several investigational tools are explored to help build up knowledge of techniques that might be used by a company to provide a structure for systematic investigation of failure. Numerous exercises are run throughout the course to provide realistic examples of events requiring investigation, providing an opportunity to practice investigation and writing up of corrective actions within teams. Examples of the use of, and outputs from, more complex techniques are presented. Suitability 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. Learning Outcomes 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
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Tel: +44 (0)118 918 4076 E-mail: [email protected] Bookings: [email protected] Web: www.rssl.com
RSSL Training
The Reading Science Centre, Whiteknights Campus, Pepper Lane, Reading, Berkshire, RG6 6LA
Failure Investigation andCorrective and Preventive ActionScopeThis course provides an introduction to the requirements of systematic failure investigation (FI) and corrective and preventive action (CAPA) practices as described in ICH Q9 and made a regulatory requirement in Europe by Annex 20 of the Guide to GMP, and in the USA by the Federal Register/FDA Guidance for Industry.
The course is focused on company responsibilities within a quality risk management system, and several investigational tools are explored to help build up knowledge of techniques that might be used by a company to provide a structure for systematic investigation of failure.
Numerous exercises are run throughout the course to provide realistic examples of events requiring investigation, providing an opportunity to practice investigation and writing up of corrective actions within teams.
Examples of the use of, and outputs from, more complex techniques are presented.
SuitabilityThe 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.
Learning OutcomesBy 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 andreactive situations
• Understand tools and techniques that can be used inFI to identify probable root cause
• Understand the requirements of a CAPA system foreffective implementation of actions
• Appreciate the importance of documenting theprocess used
• Identify company policy and procedure required tomeet regulatory requirements
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