FDA Home Use Device Initiative

On the Designated Representative and Exemptee Blog - News On FDA Home Use Device Initiative: the FDA may suggest devicemakers create different written instructions for the patient, prescriber of the device and the person training the consumer on how to use the device.

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Turkey Talk - Avoid Getting Sick

Thanksgiving is here. I'm reprising one of my oldie but goodie posts, Time To Talk About Turkey Cooking and Food Safety.  Follow the link to a well written set of do's and don'ts.  As a bonus there are additional links that might pique your interest.

For fewer clicks, here's the real 'meat' of the matter:
Let's Talk Turkey—A Consumer Guide to Safely Roasting a Turkey

Enjoy your safe, and well-prepared Turkey dinner!

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10 Golden Rules of GMP - Free Tips

• FDA GMP QSR cGMP Online Training - respected GMP online training courses offered by SkillsPlus International Inc.

Updated October 3, 2018

The white paper referenced in the original post is no longer available.

However, PharmOut has posted this PDF:
The 10 Golden Rules of GMP - PharmOut

- -  original post follows below  - -

This free GMP white paper from PharmOut is a great read, White Paper - The 10 Golden Rules of GMP (pdf).

You get a quick list of the 10 golden rules, an excellent explanation of each rule, and finally a self-audit checklist.

Enjoy!

#FDA #GMP #training #cGMP

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FDA cGMP QSR GMP Training

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FDA Quit Smoking Resources and the Great American Smokeout

• Trusted FDA GMP online training courses and programs by SkillsPlus International Inc.

Celebrate the Great American Smokeout by checking out FDA Resources for quitting tobacco use, and more.

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Drugs and Supplements From China Still Largely Unregulated

• Pro Tip:  FDA GMP QSR cGMP Online Training - highly recommended GMP online training courses offered by SkillsPlus International Inc.

Updated February 9, 2021

Links in the original post broke.

People also ask about:

Safeguarding Pharmaceutical Supply Chains in a Global Economy - FDA.gov

- - -  original post follows below  - - -

Probably not surprising, and certainly disappointing, as reported by this KansasCity.com news article, Drugs, supplements come to U.S. from China largely unregulated.

I'm most concerned about, "One consequence of the lack of regulation has been a rising number of counterfeit drugs."

Related links:
GAO Report Blasts FDA for Failure to Implement 2008 Recommendations

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Shocking FDA Images For Cigarette Packages

• FDA cGMP online training programs and courses by SkillsPlus International Inc.

Wow! These are high impact and jarring images. You have to check out what the FDA is proposing as new required warnings, consisting of nine new textual warning statements accompanied by color graphics depicting the negative health consequences of smoking, Proposed FDA Graphic Health Warnings for Cigarette Packages and Advertisements.

More Information:
FDA Proposed Cigarette Product Warning Labels

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FDA GMP Books - Limited Previews

Image via WikipediaI'm a big fan and user of many of Google's offerings. 

While wandering through Google Books, I ran across these limited previews of these three FDA GMP-related books. I thought you might be interested.  Although the previews are limited, there's certainly enough content that can be read for learning, and plenty to review if you're considering buying the book.

Interpretation of FDA's Quality System Regulations (QSR) With QSIT references By Medical Device School (Google books preview)

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Google books preview)

Buy the book:  The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition 

Good manufacturing practices for pharmaceuticals (Google books preview)

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Staying Alive - New AHA 2010 CPR Technique (video)

This is a major change.  Watch this video to learn about the American Heart Association (AHA) 2010 Guidelines for CPR.  The guidelines mention the song Stayin' Alive for the compression rate of 100 beats per minute. 



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