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FDA Requires Additional Labeling

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(FDA: Silver Spring, Maryland) -- The Food and Drug Administration (FDA) recently issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and l

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.”

PQSystems Chartrunner link

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Study: Reasons for Work Burnout, Solutions

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(WFD Consulting: Boston, Massachusetts) -- WFD Consulting, an expert in work-life, talent management, workload, and overwork, recently released research findings that demonstrate how longer work hours and time spent on low-value work increase burnout and negatively affect employees and productiv

PQSytems Chartrunner Companion

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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.

Building Integration

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Abiding by strict environmental rules can at times seem as much like a religion as a lifestyle. It’s often difficult and even conflicting to balance the intention to live “green” with the attractions of modern convenience.

Using a Wiki to Implement a Quality Management System

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The approach of using a Wiki to document a quality management system (QMS) may seem overwhelmingly obvious in a year or so, yet we are far from that today.

Zeiss Duramax link

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Zeiss Duramax Companion

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