USP 621 Harmonization - Method Scaling

Solving Problems That Matter - a Waters webinar series featuring USP speakers

Episode 1: USP 621 Harmonization - Method Scaling

Summary

On December 1, 2022 a harmonized standard for General Chapter <621> Chromatography was released. This standard incorporates the USP with 2.2.46. Chromatographic Separation Techniques European Pharmacopoeia (EuPh) and 2.01 Liquid Chromatography Japanese Pharmacopeia (JP) texts. Harmonization of these regulatory guidance provides increased method flexibility through the employment of modernized of chromatographic tools without the need for full monograph re-validation.

Key Learning Objective: Learn how to modernize your LC system and reduce operation costs using the USP <621> allowable adjustments.

Who Should Attend: Scientists and lab managers involved with compendial methods with a drive towards modernization, productivity and compliance.

Presenter: Amanda Guiraldelli, Ph.D. (Scientific Affairs Manager, U.S. Pharmacopoeia)

Amanda Guiraldelli has been with USP since 2012 and holds the position of scientific affairs manager and principle scientist in the compendial science group-general chapters. She also serves as scientific liaison for the USP Measurement and Data Quality Expert Committee, where she works to develop and revise USP standards related to analytical procedure lifecycle/validation. Previously, Amanda worked as senior scientist at the USP reference standard laboratory for 8 years with characterization of compendial standards. She is visiting professor at the Institute of Chemistry at the University of Campinas (UNICAMP) in Brazil and is a frequent speaker and instructor on topics related to analytical procedure life cycle, Analytical Quality by Design (AQbD) and Chromatography. Amanda is specialist in mass spectrometry, chromatography, omics and chemometrics and has more than 15 years of experience in pharmaceutical R&D areas. Prior to joining USP, she was R&D scientist in a brazilian pharmaceutical industry and visiting scientist at TU Berlin in Germany and Leiden University in Netherlands (Center for Proteomics and Metabolomics) working on proteins characterization by LC-HRMS and procedure development using UHPLC-HRMS. Amanda is graduated in pharmacy biochemistry and holds a Ph.D. in analytical chemistry from the FCFRP - University of São Paulo (metabolomics by UHPLC-HRMS, GC-MS and 1H NMR and chemometrics).

Presenter: Catharine Layton (Principal Scientist, Scientific Operations, Waters Corporation)

Catharine is a Principal Scientist on the QA-QC Team at Waters Corporation located in Milford, MA. She works closely with technical experts to develop and provide the appropriate instrumentation and methodology for laboratories throughout the world. She began her career in Biopharmaceutical Development R&D at a fast paced, contract research organization and drug development laboratory where she was responsible for the design of analytical methods used to characterize novel biological therapeutics formulated by key research organizations. Catharine later moved into large pharma and analytical instrument development, where she has dedicated many years to the advancement and implementation of analytical testing strategies and methodology.

Moderated by: Isabelle Vu Trieu (Pharmaceutical Market Development Manager, Americas, Waters Corporation)

Isabelle is a business development professional dedicated to delivering benefits to analytical scientists in the life sciences industry. With over 20 years of experience in providing chromatography and mass spectrometry solutions, Isabelle is particularly interested in helping pharmaceutical scientists achieve the data quality and integrity needed to drive decisions for drug quality, safety and efficacy. Isabelle joined Waters in 2009 and currently manages the development of the pharmaceutical market in the Americas. She holds Masters’ degrees in Chemistry from Columbia University and the University Claude Bernard in Lyon, France as well as a Chemical Engineering degree from Ecole Supérieure de Chimie Physique Electronique in Lyon, France.