ICHQ14 and USP Chapter <1220>: historical perspective and the path forward in Analytical QbD

Description:
In recent years we have seen growing interest around new approaches for method development and validation. The advancement in tools to facilitate the implementation of quality by design principles have been critical. 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. The presentation will discuss similarities and differences of USP <1220> Analytical Procedure Lifecycle and ICH Q14 Analytical Procedure Development

Speaker: HORACIO PAPPA - US Pharmacopeia
Dr. Pappa has been with USP since 2003. He is currently the Senior Director of the General Chapters Department, Global Science division of the USP. He provides scientific leadership to a team of scientific liaisons responsible for the activities of seven different expert committees that cover the majority of the USP General Chapters. Horacio earned his Ph.D. in Pharmaceutical Chemistry from the University of Buenos Aires. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to Chromatography and Validation. Prior to joining USP, he worked in the pharmaceutical industry in QA/QC. Horacio held the position of Assistant Professor of Quality Control in the Faculty of Pharmacy at Buenos Aires University, and Executive Secretary of the Argentine Pharmacopeia in the period 1997-2001. He is a Quality Engineer certified by the American Society for Quality.