Free Webinar: ICH Q2(R2) & ICH Q14: A practical approach to analytical method development and validation

The ICH guidance document on Validation of Analytical Procedures, ICH Q2, has been updated to Q2(R2) and will be effective from June 14th, 2024. It includes some mandatory additions to each validation aspect and some discretionary changes, mostly focused on how to perform and evaluate the method set-up phase. This revision not only updates the approach to analytical method validation, but also sets new standards for precision, accuracy, and consistency in pharmaceutical analysis. 

This webinar aims to provide practical application examples of method validation, according to the updated guidelines. Our experts will analyse and discuss the development and validation of an LC-MS method for the determination of nitrosamines, by detailing step by step the necessary evaluations to validate for each study parameter, according to the new mandatory requirements.

The discussed validation strategy, that will focus on implementing the actual changes, can be an overall application to all chromatographic techniques, without the need of dedicated instrumentation or specific software. The planned and further execution of the design of experiment, for method development of the analytical activity in accordance with ICH Q14, even if not mandatory will also be considered.

• Overview of the principles of ICH Q2(R2) and Q14 guidelines.
• Case study: Complete validation strategy according to ICH Q2(R2) discussed step -by-step.
• Brief analysis of the design of experiment developed for the setup of the method according to ICH Q14.

Matteo Galbiati
Matteo obtained his Master Degree in Medicinal Chemistry and Pharmaceutical Technologies in 2016, from University of Milan. Immediately after, he started his experience in Eurofins BioPharma Product Testing Italy, Pharmaceutical division, as GMP Laboratory technician, within the Method Setup and Validations team. About a year later he became Project Leader in the same team, deeply focused already on LC-MS methods setup and Nitrosamines testing. Since 2021 he’s in charge of the team, as Laboratory Manager. At the beginning of 2022, he became Laboratory Manager also of the Compendial Methods Verification team, within the same Division.

Serena Nembri
Serena obtained her Master Degree in Chemistry in 2016, from University of Milan Bicocca with a thesis in the area of Chemometrics and QSAR. She started her experience in Eurofins BioPharma Product Testing Italy - Pharmaceutical division as GMP Laboratory technician in 2017, within the Method Setup and Validation team. In 2023 she became Project Leader in the same team, mainly involved in LC-MS methods setup and Nitrosamines testing. Since 2020 she’s deeply focused on the design of experiment application and statistical aspects of Method Setup and Validation studies.