According to Cerulean Associates' Why Quality by Design? - An Executive's Guide to the FDA's Quality by Design (pdf), "Quality by Design is one of the most misunderstood and misused tools available to biopharmaceutical and medical device executives." The guide is easily understood and closes by driving to a 7-step QbD start-up plan. According to the guide, "the best way to assess how to implement QbD in your organization without making the same mistakes that other companies have made is to utilize a simple 7 step process."
Here's to hoping you enjoy and find this guide a good read, as I found it.
Related Posts:
Quality by Design (QbD) For Analytical Methods (video)
#FDA #GMP #training #cGMP
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store
Monday, March 2, 2009
FDA Quality by Design - QbD - Executive Guide (pdf)
Subscribe to:
Post Comments (Atom)
Posts
1 comment:
Austin, I appreciate your comments! Any suggestions for improvement you have, I'd love to know. I'm always writing articles on QbD based on my experience helping clients and trying to make my writing as reader-friendly as possible.
john avellanet
managing director
cerulean associates llc
http://www.ceruleanllc.com
Post a Comment