North Jersey Chromatography Group

Dr. Amanda Guiraldelli is graduated in pharmacy biochemistry and holds a Ph.D. in analytical chemistry from the University of São Paulo, Brazil. Focus of her thesis was plant metabolomics by UHPLC-HRMS, GC-MS and 1H NMR and AQbD. Currently, Dr. Amanda Guiraldelli is scientific affairs manager at U.S. Pharmacopeia and visiting professor at the Federal University of Campinas (Unicamp) at the Institute of Chemistry mentoring students in research projects on AQbD. Amanda is specialist in chromatography and mass spectrometry and has more than 12 years of experience in R&D areas, with strong expertise in analytical procedure development & validation, AQbD, stability studies of drug products, analysis of pharmaceutical impurities & degradation products, chemometrics, omics science and characterization of compendial standards. Previously, Dr. Amanda Guiraldelli worked as senior scientist at the USP reference standard laboratory for 8 years with characterization of compendial standards.

Stephen is an Analytical Chemist currently working as the Operations Manager for the British Pharmacopoeia team at the UKs Medicines and Healthcare products Regulatory Agency (MHRA) where he provides support to the Analytical Quality by Design Working Party of the British Pharmacopoeia. Stephen previously held positions at AstraZeneca in chemical development and Sanofi in Technology transfer, both an as analytical chemist.

Dr. Pappa has been with USP since 2003. He is currently the Director of the General Chapters Department, 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..

Richard Verseput has over 25 years of experience applying Quality by Design tools and methods in various industries, including Aerospace, Electronics, Chemical, and Pharmaceutical. For the last 18 years Mr. Verseput has focused on adapting QbD tools and methods to Analytical R&D with a specific emphasis on the development and validation of HPLC methods. During that time he has worked with LC instrument manufacturers and global pharma customers to develop and advance QbD-aligned experiment automation and chromatography data modeling, and has taught Analytical QbD training courses to pharma companies worldwide. Richard Verseput is currently president of S-Matrix Corporation. S-Matrix is the developer of Fusion QbD® – a regulatory compliance supporting software platform which automates QbD experimentation, peak tracking, and data modeling for the development, robustness optimization, and validation of chromatographic methods.