FDA Quality by Design - QbD - Executive Guide (pdf)

Updated 6/25/2015:

The original post contains broken links.

You might also be interested in:  Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications by Mr. UMESH PATIL

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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)

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