NERCSQA Webinar: Quality by Design Using a Risk Based Approach
Presented by:
Bernadette Bowen This online webinar will be given via Zoom.
Although Quality by Design (QbD) is a well-established concept in clinical research, many organizations continue to face challenges in effectively implementing it to enhance the quality in their clinical trials. Routine monitoring, standardized protocol development, and traditional practices of managing clinical trials often fall short, leading to quality gaps that require costly remediation. But what is quality by design and how can a risk-based approach be used? While there is no official definition, according to ICH E6(R3) quality by design identifies “the factors (i.e., data and processes) that are critical to ensuring trial quality and the risks that threaten the integrity of those factors and ultimately the reliability of the trial results.” A risk-based approach enables sponsors to proactively identify and manage risks that significantly impact critical-to-quality (CtQ) factors, as outlined in ICH E8(R1), throughout the study lifecycle.
This presentation will provide practical guidance on applying QbD principles using a proportionate, risk-based approach—before trial initiation and throughout conduct—leveraging insights from ICH E6(R3) and E8(R1) to enhance clinical trial quality.
Even though this event is complimentary for NERCSQA members, you must continue to checkout to complete your registration. After registering, you will receive further instructions on how to access the webinar via email in 1-2 business days.