The Future of

Bio/Pharmaceutical Analysis

Online Summit 2024

Now On-Demand

Speakers

20 June

Speakers

Amanda Guiraldelli Mahr

Amanda Guiraldelli Mahr

Scientific Affairs Manager

USP

USP logo

Amanda Guiraldelli has been with USP since 2012 and holds the position of scientific affairs manager and scientific liaison of the USP Measurement and Data Quality Expert Committee, where she works to develop and revise USP standards related to analytical procedure 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 and Analytical Quality by Design (AQbD).

Amanda is specialist in chromatography, mass spectrometry, omics and chemometrics and has more than 15 years of experience in pharmaceutical R&D areas. 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).

Presentation

5.45 – 6.15 pm CET

ICH Q2(R2)

The latest ICH guideline for analytical procedures validation

After almost two decades, ICH Q2(R1) guideline on validation of analytical procedures have been revised to integrate knowledge management principles while broadening its applicability to encompass a diverse array of technologies and address multivariate procedures helping support the validation of Real Time Release testing (RTRT). ICH Q2(R2) became official in November of 2023 and this session will:  

  • Outline key changes in ICH Q2(R2)
  • Examine the risk-based approaches for validation of analytical procedures
  • Explore how the new guidelines align with other international recommendations
  • Explore the implications of Q2(R2) to industry.
Amanda-Guiraldelli with USP logo

Amanda Guiraldelli Mahr

Scientific Affairs Manager
USP and scientific liaison for the USP Analytical Procedure Lifecycle Joint Subcommittee (JS)