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Improve Risk Management and Quality Across the Value Chain by Increasing Visibility

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Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world.

Power Moves: Turning Compliance Into True Quality

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Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article may turn out to be a real bomb, or worse, a complete snoozer.

Life Science Regulations, Compliance, and the Move Toward QMS Software

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Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity.

Taking a Risk-Based Approach to Drug Inspections

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As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.

FDA Milestones

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Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?

Proactive Processes in High-Reliability Organizations

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Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated.

Inside Quality Digest Live for Jan. 25, 2019

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We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of t

Inside Quality Digest Live for November 30, 2018

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One of our favorite things on our show is to welcome guests, either via Skype or live in the studio. And this week, we were joined by three of our great partners. Here’s a closer look:

Interview: Nicole Radziwill of Intelex

Inside Quality Digest Live for Nov. 16, 2018

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In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.

The Benefits of a Connected Quality Platform

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BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapi

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