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 Root Cause Analysis to CGMPs, ISO 13485, ISO 9001, ISO 14971, and six sigma initiatives.
Describing the Event or Trend - Harder than it sounds.
Impact Assessment or Containment.
The 7 Key Tools -- Powerful, Effective yet Simple and Easy to Use.
Investigation Detail - Root or Probable Cause.
Root or Probable Cause Impact Assessment or Containment.
Correction, Corrective Action, Preventive Action.
Effectiveness -- Determining and Monitoring.
Considered by means of a Case Study.
Who Will Benefit :
This webinar will provide valuable assistance to all regulated companies that need their in-house personnel trained in simple but powerful tools that will trace problems to their source or root cause. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
Senior management
Regulatory affairs
Quality Assurance
Production
Engineering
All personnel tasked with problem solving
ROOT-CAUSE-ANALYSIS-SOFTWARE
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