Updated 3/10/2020:
This topic is seriously out of date. This thread started in 2008.
You might also be interested in this FDA slide presentation from 2011:
Quality by Design Approaches to Analytical Methods -- FDA Perspective
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Updated 8/10/2016:
You might also be interested in this blog post:
FDA Doubles Down on QbD (BioProcess Blog)
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Updated 6/25/2015:
This post didn't age well, the links in the original post are no longer found.
You might also be interested in: QbD Considerations for Analytical Methods - FDA Perspective
========= original post below =========
Maribel Ross, Senior Editor with Pharmaceutical Technology, discusses the FDA's quality by design (QbD) initiative as it applies to analytical methods with one of the top experts in this area, Dr. Moheb Nasr, Director of FDA's Office of New Drug Quality Assessment, in this PharmTech TV video, "Live From 2008 AAPS: Analytical Methods for QbD."
#FDA #GMP #training #cGMP
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