Developing an Effective CAPA Management and Root Cause Analysis System

• OVERVIEW

In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily. 

• 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

• WHY SHOULD YOU ATTEND

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. 

• AREAS COVERED

CAPA Definition

• When is a CAPA required
• Developing crucial pieces of a strong CAPA plan

• Root Cause Analysis Methods
  • Discussing various Root Cause Analysis methods and their benefits
• Establishment a CAPA Plan
  • Project Summary development
  • Individual responsibilities involved
  • Finalizing Completion Dates
  • Creating meaningful effectiveness checks
• Managing the CAPA System
  • Maintaining proper documentation of the CAPA plans
  • Ensuring CAPA plans are progressing
  • Proper close out of CAPA plans

• WHO WILL BENEFIT?
• Quality Control Personnel & Management 
• Manufacturing Personnel & Management 
• Senior Management
• Regulatory Affairs Personnel & Management 
• Quality Assurance Personnel & Management 
• Supplier Quality Personnel & Management