Tuesday, March 16, 2010

FDA Warns Daylight Savings Might Create Problems For Medical Devices

Updated October 16, 2024

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A Call From Health Care Providers and a Patient to End Daylight Savings Time - Clinical Diabetes:
https://doi.org/10.2337/cd24-0040

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Updated October 7, 2022

The original link broke.

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When I went to work yesterday, under Daylight Savings Time, my meeting times for recurring meeting times in a popular web meeting software application were inconsistently wrong. Now apply the time change problem to medical devices.

The FDA advises in, Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way:
"If you have any medical equipment that uses, creates or records time information about your diagnosis or treatment and the manufacturer has not updated it, the equipment may not work properly when Daylight Saving Time (DST) starts and ends."
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Saturday, March 13, 2010

Dietary Supplements - Tips for FDA Inspection

If you're involved in the manufacturing of dietary supplements, you might find this article by Amy Caplette a helpful read, Inside a GMP Inspection.  She recounts her inspection experience and provides some tangible tips that you can follow before you get inspected.

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Monday, March 8, 2010

Rx-360 Consortium Pilots Audit Sharing


From the Rx-360 An International Pharmaceutical Supply Chain Consortium:

"Rx-360 is a consortium being developed by volunteers from the Pharmaceutical and Biotech industry which includes their suppliers. The purpose is to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain. The individuals developing this concept are working in the best interest of patients. We are a non-profit organization with the mission to create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by guaranteeing product quality and authenticity throughout the supply chain."

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Saturday, March 6, 2010

Drink 3 to 5 Glasses of Red Wine to Prevent Heart Attacks

Tempranillo varietal wine bottle and glass, sh...Image via Wikipedia
Updated April 23, 2024

The original link broke.

You can still read about the same topic:


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I was originally disappointed when I first scanned this Medical News Today article, Resveratrol May Replace Aspirin As Heart Protector; Longevinex® First Branded Resveratrol Pill Successfully Tested During Heart Attack.

As a red wine lover, my disappointment turned to joy when I read this:
The amount of resveratrol in 3 to 5 glasses of red wine is only about 3-5 milligrams, but the heart protective effect is believed to be produced by the total polyphenolic molecules in a glass of dark, aged red wine, ~60 milligrams per 5-ounce glass. The optimal health benefit derived from red wine is achieved at a consumption level of 3-5 glasses, which would be considerably more expensive than a resveratrol pill, and certainly pose the problem of inebriation.
In a nutshell, I get to drink red wine to, pardon the pun, to my heart's content!

For Wine Lovers:
Wine Lovers Dishwasher Magnet

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Tuesday, March 2, 2010

FDA GMP Top 20 Countdown - Better than Letterman

Updated September 10, 2019

The original post didn't age well.

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FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.


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For the next several weeks, watch the Top 20 Count Down GMP Observations.  This series is hosted by SkillsPlus International Inc.  Just go to the SkillsPlus International Inc. home page and click on the "Top 20 Count Down GMP Observations" hyperlink (on the left navigation) for the weekly count down presentation.

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