The Harmonization of the USP General Chapter 621 Chromatography
Solving Problems that Matter: Risk Mitigation in the Pharma QC Laboratory
Expert Insights 3-Part Webinar Series: Risk Assessment, Control Strategies, and Intuitive Innovation to Improve Data Quality, Data Integrity and Lab Productivity.
Pharma QC labs are facing increasing pressure on the cost of quality while maintaining compliance and assuring patient safety. From the harmonization of USP <621> to Empower™ workflows supporting data integrity to improving method transfer outcomes, you will learn from subject matter experts how to reduce errors and mitigate risk for reproducible data and enhanced productivity.
Who should attend
- Pharma QC Lab directors, managers and senior scientists with a drive to reduce errors, improve lab productivity and enhance data quality & integrity.
PART 1 l The Harmonization of the USP General Chapter <621> Chromatography
- Wednesday, August 2nd, 11:30-12:30 ET
This webinar will cover the harmonization process of the USP general chapter <621> Chromatography (harmonized with Ph. Eur. And JP) which became official in the USP-NF on December 1, 2022.
In this seminar, major changes and their implications will be discussed including changes in terminology and definition of chromatographic parameters, new system suitability requirements and allowed adjustments of chromatographic conditions for gradient elution.
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).
