QbD is about prospectively examining the objectives of a clinical trial and defining those factors that are critical to meeting those objectives. This requires thinking differently about clinical trials. In order to do that effectively, we have provided tools below to help introduce your team to QbD concepts and how they apply in clinical trials. The sections include: understanding QbD; exploring critical to quality factors (CTQs) through the QbD Principles Document; and applying QbD through workshop tools.
Understanding QbD?
For this component, reference the earlier section in the Toolkit on Learn about QbD. You can also review CTTI's QbD Recommendations.
QbD Principles Document
The Principles Document can be used to promote proactive, cross-functional discussions and critical thinking at the time of trial development about what is critical to quality for a specific trial, and about the events that might impede or facilitate achieving quality.
Workshop Tools
Hold a workshop to educate attendees about QbD and how to apply the QbD principles through hands-on exercises during breakout sessions. Case studies, facilitator tips, and presentation slide templates are provided. You can also leverage the past CTTI QbD workshop materials.