NCCSQA Quarterly Meetings

NCCSQA 3Q Program

Friday, 21 September 2018

BASF Agricultural Solutions Seed US LLC
407 Davis Drive
Morrisville, NC 27560

Quality by Design: Applying Clinical Trial Principles to Preclinical Studies
Presented by Jennifer Stanislawski, MS, RAC, MT(ASCP), Atlantic Research Group

In 2015, the Clinical Trials Transformation Initiative (CTTI), in order to increase the quality and efficiency in clinical trials, put forth recommended principles and tools that they called Quality by Design (QbD). The intent of QbD was to understand what data and processes lend to a successful trial by identifying and managing important and likely risks upfront in order to improve the quality and outcomes for clinical trials. In this presentation, the audience will learn the history behind and what QbD is about, a real life example of how the concept is being used, and how it can be translated and applied to GLP.

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