The U.S. FDA`s CAPA 2014

Topics

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

Who should Attend

• Regulatory Affairs
• Senior management
• Production
• Quality Assurance
• All personnel tasked with problem solving
• R&D and Engineering