The Association of Clinical Research Professionals
QMS Essentials for Sites and Sponsors Under ICH E6(R3) Guidelines
The clinical research industry is shifting from a “detect and correct” mindset to a proactive, prevention‑focused approach to quality.
This course introduces the essential components of a modern, risk-based Quality Management System (QMS) and reflects the updated expectations outlined in ICH E6(R3). Learners will explore how to build and maintain a QMS that protects participant safety, ensures data integrity, supports effective sponsor and site oversight, and promotes ongoing regulatory compliance. Through practical scenarios, you’ll examine how Quality-by-Design (QbD), Critical‑to‑Quality (CtQ) factors, and proportionate risk controls work together to minimize issues and strengthen inspection readiness.
At the end of this course, participants should be able to:
Describe the core components of a Quality Management System (QMS) and explain how they support compliant, high‑quality clinical trial conduct.
Differentiate quality planning, quality control, quality assurance, and quality improvement, and illustrate how each function integrates into a unified QMS framework in alignment with ICH GCP E6(R3).
Apply Corrective and Preventive Action (CAPA) and Root Cause Analysis (RCA) techniques to identify, correct, and prevent recurring quality issues.
Analyze risk‑management strategies and incorporate Critical‑to‑Quality (CtQ) factors and Quality‑by‑Design (QbD) principles into trial design and planning.
Evaluate key success factors for sustaining an effective QMS that promotes participant safety, data integrity, and ongoing inspection readiness.