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About
This course addresses identification and interpretation of the requirements of a Corrective and Preventive Action (CAPA) system. CAPA is a fundamental management tool that is integral to an effective Pharmaceutical Quality System (PQS).
Objectives
- Identify regulatory requirements of CAPA
- List the phases and processes of a successful CAPA system
- Explain a CAPA system’s critical elements
- Explain the importance of documentation
- Describe tracking and escalation processes
- Recognise ICH Q10 requirements of CAPA, including root cause and risk assessment
Topics
- Introduction
- CAPA systems
- CAPA system elements
- Root Cause Analysis (RCA)
- Tracking and escalation
- Conclusion
Participants
This course is designed for induction of personnel new to GMP or as a refresher for experienced GMP personnel with any (potential) responsibilities within any phase(s) of the CAPA quality system element.
Assessment / Certificate
There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 3 attempts.
Duration
The course is expected to take approximately 1 hour.
Your licence grants you access to the course for 30 days.
Refer to the Terms and Conditions.
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