Associate Principal Scientist Organon Quakertown, Pennsylvania
Description of technical and non-technical challenges faced during analytical method transfers (AMT). It also explores the impact of cultural, language, and laboratory infrastructure differences on AMT . Furthermore, it highlights how a method risk assessment tool, along with audiovisual tools, helped build capability at the receiving labs, enhancing their execution of analytical methods . The option of documenting lab qualification by comparing historical data in applicable situations will also be discussed.
Learning Objectives:
Discuss case studies for method transfers to contract laboratories labs across different organizations and the challenges faced.
Discuss how an analytical quality risk assessment tool developed to support tech transfers helped to facilitate lab qualification.
How to manage cultural, linguistic, and laboratory infrastructure differences, and how visual and audiovisual tools help enhance method execution.
Present options alternative to traditional method transfers and when applicable.
