CAPA and Root Cause Analysis: Developing, Documenting and Managing a Robust System

OVERVIEW

In order to solve problems every organization must know how to conduct an effective event investigation, identify root causes, and implement workable corrective action in a timely manner. An effective Corrective Action and Preventative Action (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.

WHY SHOULD YOU ATTEND

This webinar will include discussions on proper CAPA system maintenance, root cause analysis, documentation of CAPA 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

Definition of a CAPA

• When a corrective action and preventative action (CAPA) is needed
• Development of the essential pieces of a robust CAPA plan

Root Cause Analysis Methods

• Discussion of different Root Cause Analysis (RCA), methods and benefits of each

Establishment of the CAPA Plan

• Project summary development
• Responsibilities of individuals involved
• Establishing completion dates
• Creating meaningful effectiveness checks

CAPA Management

• Maintaining proper documentation of CAPA plans
• Ensuring CAPA plans are progressing
• Proper close out of CAPA plans

LEARNING OBJECTIVES

Learn the fundamentals of corrective action and preventative action (CAPA) and root cause analysis (RCA). Also learn the techniques of CAPA plan development, CAPA management and documentation of CAPA.

WHO WILL BENEFIT

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