Here's a nifty reference to add to your bookmarked favorites relating to pharma, biopharm, medical device, dietary supplements, and more.
NSF-DBA's Jargon Buster, lists abbreviations and acronyms, with their associated meanings.
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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)
#FDA #GMP #training #cGMP
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I'm glad to see this, as reported by Medscape Medical News, FDA Creates New Genomics Position. With burgeoning scientific advances in this area, it's great to see the FDA attempting to stay caught up with the rest of the industry sector. I remain hopeful of the FDA doing the right things, and am happy to see them being appropriately influenced, as evidenced by this quote . . . Dr. Torti said, "The FDA's emphasis on a coordinated genomics effort is the outcome of the June 2008 FDA Symposium and Retreat on Genomics, the recommendations of FDA's advisory Science Board, and our own internal planning."
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