Closed-Loop CAPA - Meeting FDA Requirements - Webinar By ComplianceOnline (FDA Compliance)
Venue: Online Event
|Event Date/Time: Oct 18, 2011||End Date/Time: Oct 18, 2011|
Repeatable, systematic Failure Investigation and Root Cause Analysis is an often discussed, but little understood discipline among those who could benefit most from its use. The most important area audited by the FDA is CAPA. One of the most cited 483 observation is failure to resolve the key underlying problem and close out CAPA documents in a timely manner -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s).
This webinar will show how regular, defined and systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.
Areas Covered in the Seminar:
- Elements of a truly "closed loop" CAPA system.
- Accurate Event Description.
- A Sample Failure Investigation Template.
- 7 Powerful Tools for Root Cause Analysis.
- Investigation Detail - Root or Probable Cause.
- Impact -- Often neglected but of major importance.
- Correction, Corrective Action, Preventive Action.
- Effectiveness -- Determining and Monitoring.