Webinar Details:

Course Description: 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.

Course Outline:

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

Learning Objectives (State one to three 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

Who Should Attend:

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

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people