Recent years have seen momentum growing around enhanced approaches to method development and validation leveraging quality by design principles. Methods developed with predefined performance criteria to assure fitness for purpose provide more robust methods with appropriate variability. This session will discuss guidelines recently published by the USP and ICH around analytical procedure lifecycle.
Learning Objectives:
Define the concept and benefits of analytical Quality by Design
Understand, compare and contrast USP GC Analytical Procedure Lifecycle Management and ICH Q14 Analytical Procedure Development
