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

Reinventing Method Validation for Environmental Monitoring
Oral Presentation

Prepared by W. Lipps
Shimadzu Scientfic Instruments, 7102 Riverwood Dr, Columbia, Maryland, 21046, United States


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.