Executive Director Eli Lilly & Company Indianapolis, Indiana
This presentation will provide the background for method transfer requirements followed by a strategy to maximize efficiency for sustained method transfers across a product lifecycle. Products that are marketed globally experience peaks and valleys for method transfers based on submission schedules. Each time methods require transfers, a number of evaluations are necessary and include identification of a batch of material, definition of study design, creation of acceptance criteria, execution of transfers (sometimes at both originating and receiving sites), evaluation of data, and determination of success, to name a few. There is a way to improve efficiency and it will be the strategy presented in this forum! After relating guidance to method transfer requirements, a strategy to build a sustainable transfer plan will be described. Finally, examples will be provided along with data evaluations to show how this transfer strategy will assist with method monitoring.
Learning Objectives:
Upon completion of this presentation, program participants will be able to design streamlined method transfer strategies.
Upon completion of this presentation, participants will be able to define sustainability for method transfers for given properties.
Upon completion of this presentation, participants will be able to define properties and monitor method performance with respect to the given property.
