COURSE DESCRIPTION

OVERVIEW

ICH E6 GCP update expects that sponsors and contract research organizations (CROs) have systems in place to prevent noncompliance and for significant deviations ensure effective action planning with follow-up. When noncompliance does occur, strong Root Cause Analysis (RCA) investigations should take place that result in effective corrective and preventive measures (CAPA). Inspection findings worldwide reveal that sponsors and investigators fail to have effective CAPA processes. These risky deficiencies comes from 1) gaps in process, and 2) gaps in the skills of those performing RCA and CAPA.

This session will provide you and your colleagues training on the essentials of CAPA and Root Cause Analysis. Neither is an inherent skill, and cannot be completed effectively with only using popular tools, (e.g., Fishbone Diagrams). This interactive session will provide you with an overview of what you need to do to prepare and successfully execute RCA investigations that will lead to appropriate interventions.  You will work through specific use cases for clinical trials to support the correct application of RCA for clinical trials. The training also includes suggestions for action planning to support application, and underscores that “practice is essential” for successful RCA and CAPA programs.

LEARNING OBJECTIVES

This 90-minute course will provide you with the essential information you need in regard to understanding CAPA and Root Cause Analysis, and application strategies. Join us and understand what has changed, what hasn’t, and discover what will matter most with these recent changes.

By attending this interactive live session, you will be able to:

1. Recognize needed changes to your strategies for trial issues management related as a result of ICH GCP E6 (R2).
2. Apply the steps of CAPA and RCA to a clinical trial use case.
3. Identify how CAPA and RCA may be applied for your role.
4. Discuss challenges and opportunities in implementing CAPA and RCA.