The Free GMP Countdown - A Few More Weeks Left

It's not too late.

SkillsPlus International Inc. is winding down their free GMP countdown. Check it out!

Just navigate to the SkillsPlus International Inc. website, and click on one of the numbered links under the left-side heading of GMP Top 20 Observations Countdown.

Happy reading!

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Free QSR Training (video)

According to the FDA, the quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements.

Checkout this free training offering by the FDA, Quality System Regulation 21 CFR Part 820 Basic Introduction (video).

Here's what you get with the complete course offering:

1. Quality System Regulation 21 CFR Part 820 Basic Introduction - Online Video Presentation (with Captioning)
2. Quality System Regulation 21 CFR Part 820 Basic Introduction - Printable Slide Presentation
3. Quality System Regulation 21 CFR Part 820 Basic Introduction - Post Test

You might also be interested in:

Essentials for Medical Device Manufacturers - a training class by SkillsPlus International Inc.

Teaches employees the essential elements of QSR for beginning work in the medical device industry

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You might also be interested in:
ISO 13485:2003 and FDA QSR (21 CFR 820) Manual, Procedures and Forms

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Prostate Health - Drink Red Wine and Green Tea

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Jackpot! Two of my favorite beverages.  During the weekday, I drink a cup or two of green tea at work. Every evening, I try to have a glass or two of red wine with dinner.

I 'm hoping the prostate health benefit is real, as reported by this FASEB Journal article, Polyphenols in red wine and green tea halt prostate cancer growth.  The Journal reports:

"In what could lead to a major advance in the treatment of prostate cancer, scientists now know exactly why polyphenols in red wine and green tea inhibit cancer growth. This new discovery explains how antioxidants in red wine and green tea produce a combined effect to disrupt an important cell signaling pathway necessary for prostate cancer growth. This finding is important because it may lead to the development of drugs that could stop or slow cancer progression, or improve current treatments."

For Wine Lovers:
Wine Lovers Dishwasher Magnet

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• Green Tea Fights Cancer (food-facts.suite101.com)
• Wine and Health ("Alcoholic beverage or nutrient?) (winebookclub.org)

Dietary Supplements - Legislation Introduced - S. 3414

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New dietary supplement legislation (S. 3414) has been introduced by Senators Harkin and Hatch, as reported by this Lexology article, Dietary supplements on the Hill - new legislation introduced.

In a nutshell:

1. It would allocate funds to the FDA to implement and enforce DSHEA.
2. It would require the FDA to make annual reports to Congress on its implementation and enforcement of DSHEA.
3. 180 days after the enactment of S. 3414, the FDA would be required to publish a guidance document on New Dietary Ingredients (“NDI”).

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• Herbal Supplements Often Have Contaminants, Study finds (nytimes.com)
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Dr. Oz Show About Dietary Supplements

Here's something that might interest you if you follow manufacturing and regulatory issues, or possible health dangers, involving dietary supplements.

This post leads you to the very popular Dr. Oz Show episode aired April 27th 2010 about dietary supplements.  The episode has been uploaded to YouTube in 5 parts.

Therefore, here's the link to part 1 of 5, The Dr Oz Show April 27, 2010 part 1 of 5.   Enjoy!

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The Real Vitamin and Mineral Book, 4th edition: The Definitive Guide to Designing Your Personal Supplement Program

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GxP Means . . .

For those who aren't quite sure what this acronym means, Nancie Celini explains what it is and the implications for GxP training in her blog post on the GxP Perspectives blog, GxP Defined: Training for FDA Regulated Industry.

The post is wonderfully packed with information and is succinctly written.

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Trackback url to the blog post cited above: http://carl1anderson.wordpress.com/2010/06/11/gxp-defined-training-for-fda-regulated-industry/trackback/

Follow FDA Sun Protection Tips

Now that Summer has arrived, it's more important than ever to protect your skin from the sun. I'm golfing lots these days, and know that I need to pay special attention to avoid sunburns.

The FDA offers a nice variety of resources and tips to help you and your family save your skin!

FDA - Sun Safety - Save Your Skin
FDA - Sun Protection

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La Roche-Posay Anthelios 60 Ultra Light Sunscreen Fluid for Face, 1.7-Ounce Bottle

FDA Cautions About Sexual Enhancement Supplements

The FDA offers these words of advice to patients, Caution about Sexual Enhancement Supplements.

An FDA investigation of a number of these sexual enhancement products found that a third of them actually contained the same or similar ingredients as those in Viagra (sildenafil citrate), Cialis (tadalafil), and Levitra (vardenafil HCl) - and sometimes in very large amounts. FDA has issued many alerts about these products over the past several years, but their number appears to be growing.

In a nutshell:

• Patients who should not take approved prescription drugs for erectile dysfunction should not take these sexual enhancement products, because they could pose similar or worse risks.
• Patients who are using prescription drugs to treat erectile dysfunction should not to take these so-called "supplements" because doing so could expose them to dangerously high doses of the active ingredient in their prescriptions.

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FDA Talks About Indoor Tanning Risks

I for one, love a good tan, and I recognize the risks.

The FDA has taken an interest in educating consumers that ultraviolet (UV) radiation in tanning devices poses serious health risks. They've created a Tanning - Welcome to FDA’s Tanning Website.

In support of the FDA transparency initiatives, they've made some of their materials available:
FDA - "Indoor Tanning: Risks of UV Radiation” presentation slides
FDA - "Indoor Tanning: Risks of UV Radiation” - 30 minute webinar

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• Study: Tanning triples melanoma risk (cnn.com)
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Coppertone Sport SPF 30 Continuous Spray Clear Twin Pack, 6-Ounce Cans
Aveeno Continuous Protection Sunblock Spray, SPF 70, 5-Ounce Cans (Pack of 3)