In this presentation I will describe technical and non-technical challenges faced during analytical method transfers. The case studies selected will include method transfers to external contract laboratories and laboratories within the same organization. Also, will discuss how the differences in culture, language, and laboratory infrastructure had an impact on transfers, and how a method risk assessment tool, plus visual and/or audiovisual tools helped build capability at the receiving labs to improve their execution of analytical methods. The option of documenting lab qualification by comparison of historical data will also be discussed for applicable situations will also be touched upon.
Learning Objectives:
Discuss case studies for method transfers to contract laboratories and internal labs across different geographies and the challenges faced on both instances.
Describe how an analytical quality risk assessment tool developed to support tech transfers helped to facilitate lab qualification.
How to navigate differences in culture, language, and laboratory infrastructure and how visual and/or audiovisual tools aid to improve method execution.
Introduce options alternative to traditional method transfers and when applicable.
