Validation of Analytical Methods -
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Published on: 8/25/2008
Last Visited: 8/25/2008
Chantal Felten, Ph.D., Industry ConsultantDr Chantal Felten has over seven years of experience leading Genentech's method validation function.During her time at Genentech, Dr Felten lead the Early Stage (Phase I/II) as well as the Late Stage (Phase III to post commercial) validation functions.In addition, she managed the commercial method transfer and troubleshooting function and oversaw clinical and commercial PCR activities.
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Prior to joining GNE, Dr Felten was a visiting scientist at Prof. Barry Karger's laboratory in Boston, MA working on proteomics through coupling of Capillary Electrophoresis to Mass Spectrometry.
Dr Felten has personally validated several key methods that are now a part of GNE's commercial control systems.As a group leader/senior scientist, she had technical oversight over countless method developments/validations for commercial and clinical filings, with over 30 successful IND/BLA filings.
Dr Felten is now working independently as a consultant and as such is consulting to GNE for Phase appropriate GMP, including approaches to validation for early stage clinical.
She has been actively lecturing and teaching on the principles of method validation over the years, with organizations such as Beckman Industries, CE in Pharmaceuticals and of course IBC.
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