Achieving Compliance with Robust CAPA Systems 2016

Topics

• Root Cause Analysis Methods
  • Discussion of different Root Cause Analysis methods and benefits of each
• Definition of a CAPA
  • Development of the essential pieces of a robust CAPA plan
  • When a CAPA is needed
• Management of the CAPA System
  • Ensuring CAPA plans are progressing
  • Maintaining proper documentation of the CAPA plans
  • Proper close out of CAPA plans
• Establishment of the CAPA Plan
  • Responsibilities of individuals involved
  • Project Summary development
  • Creating meaningful effectiveness checks
  • Establishing Completion Dates

Who should Attend

Attendees from:

• Manufacturing Personnel & Management
• Quality Control Personnel & Management
• Regulatory Affairs Personnel & Management
• Senior Management
• Supplier Quality Personnel & Management
• Quality Assurance Personnel & Management