Monday, May 30, 2011

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
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Thursday, May 26, 2011

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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Wednesday, May 25, 2011

Massive Glossary of Pharma Biotech Terms - Free

Photograph of the Taxus drug-eluting stent, fr...Image via Wikipedia
The ISPE (International Society for Pharmaceutical Engineering) has a free 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


cGMP basics training for newbies and seasoned staff

#FDA #GMP #cGMP #training #course #class

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Monday, May 23, 2011

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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Wednesday, May 18, 2011

A New Twist - Drug Dealers As Buyers

Main side effects of Oxycodone. Red color deno...Image via Wikipedia
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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Monday, May 16, 2011

FDA Orange Book - New - Updated For 2011

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)


Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

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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Wednesday, May 11, 2011

NIH Complementary and Alternative Medicine Website

Logo of the United States National Center for ...Image via Wikipedia
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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Monday, May 9, 2011

Ideas For Using Games In GMP Training

Using Games In cGMP 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:
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Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
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or


#FDA #GMP #training #cGMP

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Wednesday, May 4, 2011

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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Even More Resources, Books, & Things (many from Amazon.com)

FDA, GMPs, QSR, GCP, GLP, GXP:
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