The Free GMP Countdown - A Few More Weeks Left

• People also ask about FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
  

Updated February 8, 2021

Links in the original post broke.

People also ask about:

Inspection Observations - FDA.gov

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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)

• People also search for FDA CGMP Online Training - respected FDA GMP online training courses offered by SkillsPlus International Inc.

Updated April 13, 2021

The original links broke.

You'll also be interested in:

An Introduction to FDA's Regulation of Medical Devices - FDA.gov

PresentationExternal Link Disclaimer   Printable Slides   Transcript

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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

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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Our most popular course

Put fun back into GMP training!

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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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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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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

GxP Means . . .

• cGMP FDA GMP Training Courses by SkillsPlus International Inc.

Updated: November 6, 2016.

Some links don't age well, like the one in the original post below.

Instead, you might interested in:

ISPE Glossary of Pharmaceutical and Biotechnology Terminology

- - - - -

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.

You might also be interested in basic cGMP/QSR training:
Essentials for Pharmaceutical Manufacturers - cGMP Training
Essentials for Medical Device Manufacturers - QSR Training

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Follow FDA Sun Protection Tips

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

Updated 12/8/2022

The original links broke.

You can still read about the same topic here:

Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses - FDA.gov

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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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FDA Cautions About Sexual Enhancement Supplements

• FDA GMP QSR cGMP Online Training - popular GMP online training classes provided by SkillsPlus International Inc.

Updated February 2, 2021

Links in the original post broke.

People also ask about:

Tainted Sexual Enhancement Products - FDA.gov

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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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FDA Guidance On ICH Q8-10

• Respected FDA GMP online training courses offered by SkillsPlus Intl Inc.

This FDA guidance, FDA - Guidance for Industry - Q8, Q9, and Q10 - Questions and Answers, reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances.

The guidance, in Q & A format covers:

• Q8 (R2) Pharmaceutical Development (includes the Q8 parent guidance (Part I) and the annex (Part II), which provides further clarification of the Q8 parent guidance and describes the principles of quality by design)
• Q9 Quality Risk Management
• Q10 Pharmaceutical Quality Systems

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World No Tobacco Day is May 31st

If you're a smoker, consider trying to stop smoking on World No Tobacco Day.

On the 31st of May each year, WHO celebrates World No Tobacco Day, highlighting the health risks associated with tobacco use and advocating for effective policies to reduce consumption. Tobacco use is the second cause of death globally (after hypertension) and is currently responsible for killing one in 10 adults worldwide.

The theme of World No Tobacco Day 2010 is "Gender and Tobacco" with an emphasis on marketing to women. The campaign focuses on the damaging effects of tobacco marketing towards women and girls.

The World Health Organization (WHO) urges governments and the public:

1. to demand a ban on all forms of tobacco advertising, promotion and sponsorship
2. to support implementation and strong enforcement of legislation to provide 100% protection from tobacco smoke in all public and work places, and
3. to take global action to advocate for women's freedom from tobacco.

The World No Tobacco Website
 
Previous Posts:
Tobacco Products - Big Pharma Takes On Big Tobacco
FDA Restricts Cigarette and Tobacco Sales and Distribution
Tobacco Will Kill Millions Next Year
FDA Launches New Tobacco Products Center
 
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Global Drug Supply - Counterfeit Drug Debate Heats Up

One would think that it should be fairly straightforward to drive fake and counterfeit drugs out of the global drug supply chain. It turns out there are polarized viewpoints and specific interests by many involved, as reported by SecuringPharma, Counterfeit drug debate heats up at World Health Assembly.

The situation boils down to, some:

". . . countries disagree with the WHO's working definition of the term 'counterfeit', which they maintain is being confused with intellectual property rights (IPR) issues, preferring instead terms such as 'falsely labelled', 'spurious' and 'substandard'."

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FDA Draft Guidance - Medical Device ISO - Voluntary Audit Report Submission Program

The Federal Register notice just announced the availability of the FDA Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program.

The medical device ISO 13485:2003 Voluntary Audit Report Submission Program outlined in this draft guidance is another way in which FDA may leverage audits performed by other Global Harmonization Task Force (GHTF) regulators and accredited third parties in order to assist the agency in setting risk-based inspectional priorities.

The FDA recommends that a domestic or foreign device manufacturer that is subject to the requirements in 21 CFR Part 820, Quality System (QS) regulation be eligible to participate in the ISO 13485:2003 Voluntary Audit Report Submission Program under certain circumstances described on the FDA webpage (link provided above).

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Tobacco Products - Big Pharma Takes On Big Tobacco

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This is an interesting battle that's emerging, according to Timothy Carney in his article, Big Pharma rumbles with Big Tobacco on products.

The viewpoint provides a good grounding of the tobacco product landscape, and the emerging industry heavyweights positioning to do battle for government influence and ultimately consumer dollars.

Who's going to win?

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FDA Focus On Contact Lens Use And Safety - Medical Device

Approximately 30 million U.S. contact lens wearers use a variety of lens care products available in most pharmacies. Improper care of contact lenses can lead to a variety of eye infections. Over the past few years the FDA has been working to reduce risks of eye infections.

The FDA reinforces the latest thinking in its post, Looking Good: Safe Use and Care of Contact Lenses (May 2010).

For even more information, go to the webpage, FDA Contact Lenses.

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