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

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

Register for our upcoming webinar with 247Compliance on February 16.

You can find all the information in the link below:

http://bit.ly/3lpadt2