A practical breakdown of how monitors, auditors, and FDA inspectors each contribute to quality oversight, compliance, and inspection readiness across the clinical trial lifecycle Adapting Auditing Practices & Processes for ICH E6 (R3)
The Society of Quality Assurance Annual Meeting is a key event for quality and regulatory professionals across the life sciences industry, bringing together experts to share insights and best practices in an evolving compliance landscape.

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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