This CAPA training course will help you investigate problems in a quality system. PathWise uses an interactive approach to show how to effectively apply risk-based methodology throughout the investigation process. As a result, course attendees will be ready when problems occur, and ready to prevent future problems. Specifically, PathWise focuses on how you identify issues and we instruct how to assess and prioritize these issues, or non-conformances. The course also covers how to investigate to root cause, and implement corrective and/or preventive actions. Ultimately, our investigations and CAPA course can support your organization to reduce repeat CAPAs, and improve root cause identification.

The PathWise Investigations and CAPA training course covers four modules. These modules explore the following learning objectives:

INTRODUCTION

Identify and distinguish between a correction, corrective action and preventive action.
Identify regulatory requirements for Investigations and CAPA
EVALUATE

Write effective problem statements
Conduct Risk Analysis and assess impact
Understand and use techniques for interviewing
INVESTIGATE

Gather specifics
Conduct root cause analysis.
Systematically find cause(s)
Establish causal relationships
Use quality tools: 5 Whys, Fishbone, IS/IS NOT
Identify a process to verify root cause
IMPLEMENT

Identify a process to implement corrective/preventive actions.
Understand project management tools available
Write a strong Corrective/Preventive Action
Understand effectiveness check and verification requirements
Manage and track actions in implementation