Robust Corrective And Preventive Action (CAPA) 2013

Topics

• CAPA Background
• Regulatory "Hot Buttons"
• Impact Analysis and Response - a Key Component
• Correction, Corrective Action, Preventive Action Defined
• "Bullet-Proof"
• CAPA System Assessment
• Monitor for Effectiveness
• Data Sources / Metrics
• Beyond Regulatory Compliance
• "Closed-Loop" - Lock In the Change

Who should Attend

• Middle management
• Senior management
• Engineering
• R&D
• QA / RA
• Software
• Operators
• Manufacturing
• CGMP instructors
• Consultants