actON QbD | Episode 1: Critical to Quality Conundrum
Understanding Critical to Quality Factors (CTQs) in Clinical Trials
Critical to Quality Factors (CTQs) are fundamental to implementing Quality by Design (QbD) principles in clinical research, as emphasized in ICH E8(R1) and E6(R3) guidelines. But what exactly is a CTQ? Why does it matter in practice? And how can your team effectively identify and apply CTQs to ensure trial success?
In this interactive mindsON session, we’ll unpack the concept of CTQs and explain their role in supporting patient safety, protocol integrity, and data reliability across the clinical trial lifecycle.
What You’ll Learn:
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What is a CTQ?
Get a clear definition of Critical to Quality Factors and understand how they link to key trial objectives. -
Why are CTQs important?
See how focusing on CTQs helps identify high-risk areas, reduce avoidable errors, and ensure GCP compliance. -
How to apply CTQs effectively?
Learn how to use Cyntegrity’s MyRBQM® Portal to define, monitor, and manage CTQs in real time connecting risk indicators with quality oversight. -
Where do CTQs fit within QbD and RBQM?
Explore their integration with study planning, centralized monitoring, and continuous risk assessment.
Who Should Attend?
This session is ideal for:
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Clinical Quality Managers
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Risk-Based Monitoring Teams
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Clinical Operations Professionals
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Data Managers
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Medical Monitors
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Regulatory Affairs Experts
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Anyone involved in QbD, QMS, or RBQM implementation
Why It Matters
CTQs are not just theoretical concepts they are practical tools that can make or break the success of your clinical trial. Identifying them early, monitoring them consistently, and acting on related risks are key to delivering faster, safer, and more reliable research outcomes.
Don’t Miss Out!
Join us to discover how Critical to Quality Factors can transform your approach to trial planning and oversight. Whether you’re new to QbD or looking to strengthen your RBQM practices, this session will equip you with actionable insights and a hands-on demo of how CTQs are used inside the MyRBQM® Portal.
