FDA Wants Resource Planning In Corrective Action Plans

According to the The QA Pharm blog,

"The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work."

Apparently in an FDA Warning Letter to Teva early this year,  the FDA is telegraphing their desire to see these kinds of elements in a response:

• a plan
• what kind of data will be collected to measure the effectiveness of the plan
• a timeline for the plan
• the identification of resources allocated to address the issue

You might also be interested in:
CAPA for the FDA-Regulated Industry (Kindle)

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FDA Says Fight Bac - Summer Food Safety

The Memorial Day weekend is here.  If you're planning to eat outdoors, be sure to follow these FDA Food Safety Tips - Eating outdoors, handling food safely - Food Facts from the US FDA

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Massive Glossary of Pharma Biotech Terms - Free

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The ISPE (International Society for Pharmaceutical Engineering) has a free Glossary of Pharmaceutical and Biotechnology Terminology.

ISPE Glossary of Pharmaceutical and Biotechnology Terminology

It's truly massive, and free!   When I clicked on English language or browsed "All", it resulted in over 7,000 terms.

You can:

• search by term or language
• browse the list alphabetically

About the ISPE Glossary

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Video Clip For FDA GMP Documentation Training From SkillsPlus

Checkout this free video clip preview from SkillsPlus International Inc.

It's a preview for online e-Learning CBT (computer-based training) on proper documentation procedures. What's cool is, there's just enough useful material in the 'long' version of the preview that you can use it as a part of your training program:  The 'long' version preview of Overcoming the Documentation Nightmare by SkillsPlus International Inc.

Here's the 'short' version of the preview:



You might also be interested in:
Computer-Based Training by SkillsPlus International Inc.

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A New Twist - Drug Dealers As Buyers

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I've always considered drug dealing to be about drug dealers peddling their wares.  Lo and behold, this NY Times article shines some light on a new phenomenon of drug dealers buying prescription drugs (for example, Oxycontin and Percocet) from folks walking by on the streets, Not Far From the Pharmacy, a Different Sort of Drug Deal.

“What you got, man?”

What a racket.

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• Who said drugs were bad? (sdcitytimes.wordpress.com)

FDA Orange Book - New - Updated For 2011

There's been a lot of interest in the FDA's Orange Book by readers. Therefore, I'm pushing this information out to folks, so that they're aware.

It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.

If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

Happy hunting!


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NIH Complementary and Alternative Medicine Website

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From the NIH (National Institutes of Health): 

NCCAM's (National Center for Complementary and Alternative Medicine) Time to Talk campaign encourages patients to tell their providers about CAM (complementary and alternative medicine) use and providers to ask about it by offering tools and resources — such as wallet cards, posters, and tip sheets — all of which are available for free at:   http://nccam.nih.gov/timetotalk/

More information for providers:  http://nccam.nih.gov/health/providers/.

Listen to the NIH Audio MP3 File: Time to Talk

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Ideas For Using Games In GMP Training

Training can be oh so boring.  So liven up your FDA cGMP training with interactive games.

Lehecka Pratt shares her solid ideas about How to Successfully Use Games in GMP Training.

Follow her recommendations, and you'll be well on your way to delivering some fun and effective training.

You might also be interested in:
Energize Your Training: Creative Techniques to Engage Learners
CGMP Classroom Teaching Tools

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Entertaining Healthcare Reform Animated Video Primer

This is really great stuff.  I have no patience to digest pages and pages of healthcare reform legislation.  This fun and informative animation makes it all very entertaining and digestible.



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