Why Should You Attend :

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.

Regular 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. Attend this Webinar to understand the 7 key tools to use for root cause analysis and impact assessment and containment. Learn how to define then attack and resolve root problems / causes, not just symptoms.

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.
• Effectiveness -- Determining and Monitoring.