At the SQA 2026 event, Erich Zirzow and Suheila Abdul-Karrim presented their poster, Practical Guide: Adapting Your Auditing Practices for the Implementation of ICH E6 (R3). The poster explores how evolving global guidance is reshaping auditing practices, with a focus on risk-based approaches, updated SOPs, and the integration of technology and data-driven methods in clinical quality systems.
This resource is especially valuable for organizations navigating the transition from ICH E6 (R2) to (R3), offering practical insight into how auditing methodologies must adapt to remain effective, efficient, and compliant in a changing regulatory environment.
At FDAQRC, we’re committed to helping clients adapt with confidence as regulations evolve. From audit services and inspection readiness to remediation and full lifecycle GxP support, our team delivers tailored solutions to strengthen quality systems and ensure regulatory success.

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Practical Guide on How to Adapt Your Auditing Practices for the Implementation of ICH E6 (R3)

Understanding Quality Oversight: Monitors vs. Auditors vs. FDA: A Quality Perspective

