CAPA and Root Cause Analysis MasterClass - US edition

Participants will gain a clear understanding of how to apply the principles of Root Cause Analysis effectively, translate findings into effective Corrective and Preventive Action plans, and embed these practices within the broader framework of Quality management system and Risk-Based Quality Management, as endorsed by ICH E6(R3).

14-15 April, 2026, Virtual
STARTING TIME EDT 08:00 A.M. | PDT 05:00 A.M. | UTC 12:00 P.M.

Overview

This online course ensures participants will gain a clear understanding of how to apply effectively the principles of Root Cause Analysis (RCA), translate findings into effective Corrective and Preventive Action (CAPA) plans, and embed these practices within the broader framework of Quality management system and Risk Based Quality Management (RBQM), as endorsed by ICH E6(R3). The course emphasizes real-world application, guiding attendees through the principles and techniques that support proactive quality management. It explores how RCA and CAPA not only resolve issues but also strengthen operational efficiency, foster cross-functional collaboration, and reduce recurrence of non-compliance.

Additionally, the course introduces how emerging AI tools can support RCA and CAPA processesenhancing data analysis, pattern recognition, and decision-makingwithout replacing the critical thinking and expertise required in clinical research.

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WHO SHOULD ATTEND

-Quality assurance Managers
-Clinical project Managers
-Clinical project Managers
-Vendor oversight Managers
-Clinical Operations Managers
-Investigational site Staff
-Clinical Research Associates
-Executives Clinical operations
-Regulatory and Safety 
-All roles in clinical research involved in incident management