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 and Content
- Introduction
- Objectives
- Reviews and assessment
- Overview
- PQS model
- Key PQS elements
- CAPA definitions
- What do the GMP rules state?
- Match the actions
- CAPA systems
- Overview
- Compliant CAPA systems
- CAPA phases
- Closed loop CAPA system
- Features
- Select all that apply to a compliant CAPA system
- What determines whether a CAPA is required or not?
- Fill in the blanks
- CAPA system elements
- Overview
- Sources of data
- Risk management
- Risk assessment
- SOP
- CAPA request
- Correction
- Corrective action
- Preventive action
- Verification and close-out
- CAPA report
- True or false?
- Why is risk management important to CAPA?
- Put these CAPA steps in order
- Which action is immediate when a problem arises?
- Root Cause Analysis (RCA)
- Example scenario
- Overview
- Root Cause Analysis (RCA)
- Investigation tools
- When to conduct RCA and CAPA
- What must be defined before a RCA?
- Match the terms
- Tracking and escalation
- Overview
- Progress tracking and escalation
- CAPA system effectiveness
- Conclusion
- Summary
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.
A PDF Certificate is issued upon passing the quiz.
Duration
The course is expected to take approximately 1 hour.
Access
For organisations looking to setup once-off or ongoing training for group of personnel, SeerPharma can create a dedicated company account in our online Learning Management System (LMS) or we can licence courses for you to host in your own LMS or QMS. Request pricing for organisations.
For individuals, you can buy now for $149 (ex GST) and your licence grants you access to the course for 30 days.
Contact us with any questions.
