Training Description:
As an aspect of GMP, CAPA is a system of measures and procedures based on investigation, which is aimed at preventing and correcting sources of non-conformities within organizations.
Corrective actions are implemented in response to customer complaints, undesired levels of internal nonconformity, nonconformities identified during an internal audit or adverse or unstable trends in product and process monitoring. Preventive actions are implemented in response to the identification of potential sources of non-conformity. CAPA is part of the overall organizations’ quality management system.
Training Objectives:
This practical training course is designed to teach participants in how to use a simple and effective approach to corrective and preventing problems or nonconformities existing within their organizations.
Upon completion of this course participants will learn to implement effective corrective and preventive actions as well as how to identify problems in advance and come up with preventive measures. They will be able to evaluate their organization`s compliance with the regulatory requirements for establishing a CAPA system.
Training Agenda:
- Background & Regulatory Requirements
- Why do I need a CAPA System?
- Why is CAPA the “Heart” of my Quality System?
- What exactly is a CAPA System and what is it supposed to do?
- What are the Essential Elements of an effective CAPA System?
- Principles of CAPA approach
- Root cause
- CAPA within your organization
- CAPA monitoring and measurement
- How do I implement an effective CAPA System?
- Q&A Session
Who should attend:
- Investigators
- Laboratory Staff
- Quality Assurance & Regulatory Affairs professionals
- Management Staff
- Manufacturing Supervisors
- Technicians
- Engineers
- Others
Fee:
59 EUR
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Date of Session:
To be confirmed
Technical Information:
Session will be conducted on-line via a web meeting. Each participant will receive a unique user ID and login to access the session.
