Achieving Compliance with Proper CAPA Systems

MessageThis Webinar is over
Date Oct 19, 2018
Time 01:00 AM EDT
Cost $200.00
This webinar will include discussions proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track.

Learning Objectives:
  • Discuss what to do when problems occur
  • Outline the requirements of the CAPA process and procedure including building a CAPA file
  • Choose the most appropriate Root Cause Analysis methods for the situation
  • Establishing a CAPA plan: project summary, individual responsibilities and expected completion dates
  • Management and Oversight of the CAPA system and its documentation
Areas Covered in the Session :
  • Definition of a CAPA
    • When a CAPA is needed
    • Development of the essential pieces of a robust CAPA plan
  • Root Cause Analysis Methods
    • Discussion of different Root Cause Analysis methods and benefits of each
  • Establishment of the CAPA Plan
    • Project Summary development
    • Responsibilities of individuals involved
    • Establishing Completion Dates
    • Creating meaningful effectiveness checks
  • Management of the CAPA System
    • Maintaining proper documentation of the CAPA plans
    • Ensuring CAPA plans are progressing
    • Proper close out of CAPA plans

Who Should Attend:
  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management


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