CAPA for Clinical Trials – How to Respond to Audit and Inspection Findings
Why Should You Attend:
The GCP Inspectorate has assessed many responses to GCP inspection reports and responses that require amendment/clarification and found that the inspector and the inspected organization spends additional time to close the inspection after responding to inspection findings. Therefore, many inspectorate and auditors are now looking for a CAPA approach to responding to inspection and audit findings as a way to improve the response to findings and also to identify the root cause of the issue.
This webinar aims to enable attendees to understand how to respond to the GCP inspection report findings using CAPA. It will also increase your awareness of the GCP inspector’s expectations and provide assistance in formulating a response.
This webinar will provide an understanding of how to run effective Corrective and Preventive Action procedures that will meet the regulator’s requirements as well as benefit the organization. The instructor will cover areas that can cause confusion including terms, definitions, deviations, discrepancies, non-conformances, documentation needed and using the CAPA approach through application of the root cause analysis technique to inspection findings.
Areas Covered in the Webinar:
- What is CAPA system?
- CAPA term and their application.
- What is CAPA and why is there so much emphasis on the use of CAPA in the regulated industry?
- Understanding regulatory requirements.
- How to investigate and use of root cause analysis to identify the root cause of CAPAs
- Documenting CAPA activities – what do regulatory inspectors expect?
- Apply and review CAPA case studies to enhance the webinar learning.
