Achieving Compliance with Proper CAPA Systems

Date	Oct 19, 2018
Time	01:00 AM EDT
Cost	$200.00
Online

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