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Quality’s Role in Biomedical Morals and Ethics

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The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand.

Life Science Pioneer Takes Cues From 21 CFR and ISO 13485

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One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years.

Top Five Things Life Science Companies Need to Know about ISO and FDA Requirements

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Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails.

Use ISO 45001 to Support OSHA VPP Star Status

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Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018.

A Survival Guide for the Era of ‘Alternate Facts’

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Last year I was invited to give a lecture on critical thinking to the U.S. Navy. I opened my presentation with a story I’d read in Reader’s Digest magazine as a child.

Inside Quality Digest Live for Nov. 2, 2018

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Our industry embodies many aspects, but “Big Q” quality generally involves issues affecting management, measurement, and methodologies. This week on QDL, we covered all of them, and more. Let’s look closer:

Preparing for Quality

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For manufacturers in diverse sectors such as automotive, aerospace, electronics, and medical device, there’s little question that ensuring great quality would be impossible without the proper testing of materials.

Occupational Health and Safety: A Standard Approach

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An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used intern

Applying the Procedures of MIL-STD-105 to Imaginary Limits

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In my first article, the merits and cautions of AS9138 c=0 sampling plans were discussed and a simple formula was provided to determine the required sample size to d

Using MIL-STD-105 As a Process Control Procedure

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In my previous article, I discussed the merits and cautions of the “acceptance number” equal zero (c=0) sam

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