Enhanced Method Development

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

Episode 3: Enhanced Method Development

Summary

Enhanced method development is a science and risk-based approach to analytical procedure development that leverages QbD principles and “starts with the end in mind”. Our panelists Amanda Guiraldelli from the USP and Richard Verseput form S-Matrix will share their insights on approaches outlined in the ICH Q14 quality guidelines and USP general chapter <1220>.

Key learning objectives:

• Discover the benefits of the enhanced method development approach
• Learn how to implement analytical QbD approaches in your lab

Who should attend:

Pharma scientists involved with analytical LC method development

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: Richard Verseput (President, S-Matrix)

Richard Verseput has over 30 years of experience applying QbD tools and methods in multiple industries. For the last 18 years he has worked with analytical instrument manufacturers, regulatory agencies, and global pharma customers to develop and advance automated QbD experimentation. Richard Verseput is currently president of S-Matrix – the developer of Fusion QbD® – a regulatory compliance supporting software platform which automates QbD experimentation, peak tracking, and chromatography data modeling for the successful development, validation, and transfer of LC and LC-MS methods.

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.