Failure Investigation and CAPA
Training
In Reading
Description
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Type
Training
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Level
Intermediate
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Location
Reading
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Class hours
14h
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Duration
2 Days
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Start date
Different dates available
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.
Important information
Documents
- RSSL Training Failure Investigation.pdf
Facilities
Location
Start date
Start date
Reviews
Subjects
- Risk
- Industry
- IT risk
- CAPA system
- Understand data
- Company policy and procedure
- Identify probable root cause
- Document processing
- Document Management
Teachers and trainers (1)
Andy Martin
Tutor
Course programme
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
This 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
- Identify company policy and procedure required to meet regulatory requirements
Failure Investigation and CAPA