Root Cause Analysis (RCA) & Corrective and Preventive Action (CAPA)

26 Apr - 27 Apr 2023

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Workshop Overview

In this interactive management course, participating managers and associates will be introduced in the important principles of Root Cause Analysis (RCA) & Corrective and Preventive Action (CAPA) methods inclusive of applying and mastering the 8-D Problem-Solving methodology effectively in their Pharmaceutical organization in relation to FDA-based current Good Manufacturing Practices (cGMP), ICH Harmonization Guidelines, and European Medicines Agency (EMA) regulations. Participants will cultivate skills and build strong organizational capabilities of systematic “risk-based prevention thinking” to the benefit of their organization’s overall management performance.

Discussions on the top challenges of RCA & CAPA, including effective planning, analysis, systematic implementation, and improvement of efficient Root Cause Analysis & Corrective and Preventive Action management in drug-producing work environments and training on the 8-D best practice problem-solving methodology in compliance with FDA Inspection observation (483) regulations, current Good Manufacturing Practices (cGMP), ICH Harmonization Guidelines and selected ISO Quality Management standards are parts of this practical training program.

The workshop empowers participants to excel as Quality Improvement Managers, as well as Quality Improvement Team members. The focus is kept on “risk-based prevention thinking” principles. On-the-job “hands-on” case studies empower attendees to effectively understand and apply methods of 8-D Problem Solving and A-3 Reporting relevant to their actual workplace.

Program Focus

The highly interactive program utilizes different methods as practical exercises and case studies, that enable participants to apply the learned RCA and CAPA management concepts and methods in their own drug-producing organizational work environment.

Within the 2-Day Workshop, participants will engage in exercise-based case studies within CAPA Regulatory expectations (drugs, biologics, and medical products) based on FDA 483 and European Medicines Agency (EMA) EudraGMD Warning Letters and GMP updates 2022, to elaborate the concepts on actual and common industry-wide operational problem-solving constellations for drug-producing industries;

Pharma industry-related examples will be discussed within risk-based prevention of so-called “human factors”. Practical interactive group scenarios, inclusive lessons learned on actual problem constellations, and how to practically apply the learned concepts in the real-life situation from their work environment (“Learning on the Job” training concept) round up the participants’ training objective.

Benefits of Attending

Upon successful completion of this program, attendees learn:

A sound understanding of the advanced core principles of Root Cause Analysis & Corrective and “Risk-based” Preventive Action management for Pharmaceutical industries
A detailed knowledge of what is needed to competently improve operational processes by applying advanced problem-solving methods for drug-producing work environments
Learn the critical success factors for FDA acceptable effective Corrective & Preventive action management, inclusive improvement project reporting based on the A-3 Storyboard
How to turn defects and problems into Opportunities for improvement and communicate improvement projects throughout the organization inclusive of human error management
New! How to prepare a professional 8-D Problem-Solving/Corrective Action Report based on “risk-based thinking” requirements of ICH Q9 Quality Risk Management
Understand the roles of Problem-solving teams and how to improve Human Factors with your corrective action system
How to monitor costs per corrective action (COQ – Cost of Quality) and customer satisfaction
Learn how to apply 8-D & A-3 Storyboard reporting together to drive effective Quality Improvement in your organization!