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New Food Safety Policy Adds to Confusion

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Resistance to the National Animal Identification Scheme (NAIS) has been strong.

ISO 13485: Creating a Globally Harmonized Quality System

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Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation.

Analyzing Data Saves Millions for County Tax Payers

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A $1 billion annual budget may sound ample, but a few years ago, the costs of services ranging from law enforcement to cleaning county buildings had squeezed the government of Erie County, New York, to its limit.

Can You Twitter Your Way to Performance Excellence?

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Verifying the Effectiveness of Corrective Action

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When I first got into quality, I really hated verifying the effectiveness of actions taken to correct a problem. After all, I was young and inexperienced. All of the people whose actions I was verifying were older, wiser, and more experienced than I was.

Part Tracking Keeps Suppliers/Customers Happy

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It’s no secret to anyone, anywhere, that we’re experiencing a global business challenge, especially in manufacturing.

How Accreditation Could Have Prevented an Outbreak of SARS

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Geoff Bilau, senior writer for the International Association for Plumbing and Mechanical Officials (IAPMO) Group, was

Value Adds to ISO 9001 Compliance

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I've been auditing to ISO 9001 since 1992. A part of my auditing philosophy has been to add value to the audited organizations by suggesting opportunities for improvement. Following, I will describe the most effective “value adds.”

FDA Importer Guidance For Devices

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The Food and Drug Administration (FDA) has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug, and food recalls.

Ultra Low Pressure Calibrators Help Pharmaceutical Operation

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Lysosomal storage disorders may not sound as dire as diseases such as cancer or Alzheimer’s, but to the people that suffer from them, life can be a nightmare.

Pagination

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