CAPA/Root Cause Analysis 2023 - CAPA/Root Cause Analysis: Achieving Compliance with Proper CAPA Systems

This webinar will include discussions on 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.
AREA COVERED
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
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 WILL BENEFIT?
Quality Control Personnel & Management
Manufacturing Personnel & Management
Senior Management
Regulatory Affairs Personnel & Management
Quality Assurance Personnel & Management
Supplier Quality Personnel & Management