GoingToMeet

This CAPA training Webinar will teach how to evaluate CAPA systems for compliance and integrate risk management and capture all sources of problem and close the loop by closing out the CAPA documents in a timely manner.

Why Should You Attend:

Corrective and Preventive Action (CAPA) continues being a major source of 483 observations. Companies claim to have fully functioning CAPA systems, often fully automated under one of several COTS QMS software programs readily available. Yet the FDA finds the situation to be otherwise. What are the key issues today -- the latest U.S. FDA findings / 483 observations? How can companies proactively address these? What part does systems entropy play in affecting a once compliant CAPA system? What are the key points to evaluate a system's compliance?

Attend this Risk based CAPA Webinar to get the above answers. We will discuss how to capture all sources of problems; how to resolve the key underlying problem and close out CAPA documents in a timely manner; and "close the loop" -- feeding CAPA data into other affected documents, plant sites, or corporate QA/RA. Where are the common disconnects? What are field reports telling us? Are we listening and responding? How can we as a company benefit in ways other than compliance?

Areas Covered in the Seminar

:
- What is the FDA looking for?
- The 7 key elements of a compliant CAPA system.
- Most likely areas for system breakdowns.
- 10 CAPA objectives your company must meet.
- Problems with the CAPA "satellite programs".
- The constant battle against system 'entropy' -- and why!
- Monitoring effectiveness -- integration of corrective / preventive action.