Failure Investigation and Root Cause Analysis - Simple Tools, Powerful Results (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: Nov 15, 2011||End Date/Time: Nov 15, 2011|
The most important area audited by the FDA is CAPA. One of the most cited 483 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). Root Cause Analysis is key to many important cGMP activities -- Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, Verification and Validation activities, CAPA, Audit corrective and preventive actions -- the list goes on.
Areas Covered in the Seminar:
Importance of Formal Failure Investigation and Root Cause Analysis to CGMPs, ISO 13485, ISO 9001, ISO 14971, and quality improvement initiatives.
- 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.
- Use in CAPA and Validation.