CAPA, Failure Investigation and Root Cause Analysis - FDA Expectations

Why Should You Attend:

The most important area audited by the FDA is CAPA - it assures the FDA that company is in compliance without the Agency constantly auditing it.

Closed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis - define, locate and resolve the basic problem(s) or root cause(s). A full-capture investigation, verification/validation, monitoring, change control methodology, coupled with accurate root cause analysis is crucial to a "closed-loop" CAPA system, that meets / exceeds CGMP requirements and U.S. FDA expectations.

This webinar will present simple but powerful tools, the systematic and regular use of which, can resolve the key underlying problem and close out CAPA documents in a timely manner. The information and tools presented in this webinar 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:

• U.S. FDA's CAPA Expectations
• What is "closed loop" CAPA?
• Correction, Corrective Action, Preventive Action
• Failure Investigation using an FI Template
• 7 Powerful Tools for Root Cause Analysis
• Investigation Detail - Root or Probable Cause
• Impact -- Often neglected but of major importance
• Effectiveness -- Determining and Monitoring
• Institutionalize vs. Entropy