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Coronavirus Risks and Opportunities

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The Chinese character for “crisis” means danger and opportunity.

The Future of Quality Management Is Business Success, Part 3

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Credit: Orlando Imperatore

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Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS).

Preparing for a New Decade of U.S. Manufacturing

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Each new year brings about a period of reflection, where one can think back on the path that the previous year took us on. 2020 represents an even larger opportunity for reflection as the world enters a new decade.

Four Types of Leadership Knowledge

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When the definition of power includes the “ability to exert influence,” then you’re also describing an element of leadership: knowledge. Take, for example, Ann Landers.

FDA Form 483 Observations and Warning Letters: What’s the Difference?

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If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens after that inspection that we’re concerned with in this article.

Critical Data Elements and Data Quality

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We are currently living in the digital age and are drowning in an ocean of data.

Is Paranoia Widespread in Your Firm? You’re Not Alone.

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Recently, I spoke to a CEO who had commissioned a survey on his organization’s health. To his great surprise—and that of his executive team—more than 80 percent of the respondents said that they were reluctant to speak their mind.

Normalcy Can Kill You

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Perhaps the worst quality failure of modern times is Boeing’s 737 Max disaster.

Manufacturing Standards for Biopharmaceuticals

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Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases.

Leaveism: Welcome to the Dark Side of 21st-Century Flexible Working

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Most people are familiar with presenteeism, where employees spend many more hours at the workplace than necessary—out of a sense of duty or to impress the boss or whatever.

Pagination

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