Have instrument, make method; How new methods are made and validated

Reinventing Method Validation for Environmental Monitoring
Oral Presentation

Prepared by

Contact Information: wclipps@shimadzu.com; 410-910-0802


ABSTRACT

This presentation examines the method development and validation process from both a manufacturer and consensus organization perspective. Often, manufacturers develop new devices for no particular reasons other than they can. New methods are created to provide a reason for the new device. Consensus organizations may or may not have procedures to determine if there is a demand. We will also look at how the consensus organizations decide to pursue a new method and what validation processes they must do.