AQbD Symposium - Day 2 - Risk Mitigation in the Pharmaceutical QC Laboratory

Enhancing the Quality of Your Analytical Procedures

Analytical Quality by Design (AQbD) is a science and risk-based approach to analytical procedure development that “starts with the end in mind”.​

Embraced by industry, regulators and academia, the application of the AQbD principles aims to improve the quality of analytical procedures by using enhanced approaches to development, validation and performance monitoring.​

Join us on November 28th and 29th to hear from subject matter experts on recent development with ICH quality guidelines, implementation in the industry, and chromatography technologies that mitigate risk in the pharma QC laboratory.​

Each session will feature a panel of 3 forward thinking leaders on the topic who will present their recent work and participate in a round table discussion.

Day 2: Risk Mitigation in the Pharmaceutical QC Laboratory

Application of Analytical Quality by Design (AQbD) principles in the pharmaceutical laboratory aims to mitigate risk in routine testing and to enable the continuous improvement of the method quality. ​

Using risk management tools, enhanced method development approaches, and innovative technology, the analytical LC method can not only be successfully transferred and deployed into routine use, but also remain fit-for purpose over its lifecycle. ​

Join us on Wednesday, November 29th for presentations by our subject matter experts followed by a live panel discussion. So have your questions ready!

AQbD as an Enabler of Continuous Quality Improvement: Building Quality During Procedure Design

Presenter: Amanda Guiraldelli (Scientific Affairs Manager, US Pharmacopeia)

Amanda Guiraldelli has been with USP since 2012 and holds the position of scientific affairs manager. She is also the scientific liaison for the USP chapters <1220> Analytical Procedure Life Cycle and <1039> Chemometrics in the compendial science group-general chapters. 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 University of Campinas (UNICAMP) Brazil at the Institute of Chemistry 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 and chemometrics and has more than 12 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 University of São Paulo (metabolomics by UHPLC-HRMS, GC-MS and 1H NMR and chemometrics).

Ongoing Analytical Procedure Performance Verification

Presenter: Phil Borman, Ph.D. (Director and Senior Fellow, GlaxoSmithKline)

Phil Borman DSc MSc MChem CChem FRSC is a fellow of the Royal Society of Chemistry with over 27 years of experience in the pharmaceutical industry having obtained a Masters in Chemistry from Manchester University, a Masters in Applied Statistics from De Montfort (Leicester) University and a Doctorate in Sciences for his work in pioneering and developing QbD approaches for analytical procedures (also from De Montfort University).

Phil is currently a Director and Senior Fellow at GlaxoSmithKline where he is accountable for the ongoing development and implementation of Quality by Design and digital platforms for Small Molecules and Biopharms. Phil pioneered the adaptation of QbD principles to Analytical procedures and has published widely in the field of Analytical Chemistry. He currently co-leads the EFPIA ICHQ2(R2)/Q14 support team as well as being vice-chair of the USP Measurement and Data Quality Expert Committee and member of the BP (MHRA) Analytical Quality by Design Working party.

Applying Quality by Design Principles to Method Transfer and Lifecycle Management of Compendial Methods

Presenter: Paula Hong, Ph.D. (Sr Manager, Research Support, Waters Corporation)

Paula Hong is a Sr Manager in the QAQC business unit at Waters Corporation. She received her B.S. in Chemistry from Bucknell University (Lewisburg, PA) and her Ph.D. in Inorganic Chemistry from The University of Pennsylvania (Philadelphia,PA). and has over 17 years’ experience in LC and LC/MS applications. She began her career at Waters in the chemistry division, focusing on novel column chemistries for biopharmaceutical applications. During the past 15 years, Paula has focused on instrument development and understanding the impact of instrument characteristics on method migration.