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I Never Want to Be [Sic]k

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Always check spelling, but don’t rely on autocorrect—read it before you send it. Photo by Lance Grandahl on Unsplash

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Reading the news (or even your email) can be distressing to the point of despondency. It can also be fun.

The Comfort Continuum

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Comfort can help or hinder growth. Photo by Katie Polansky on Unsplash

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The “comfort zone” is that cozy space where everything feels familiar and stress-free. It’s where we stick to what we know, using the same old strategies that keep things steady but can also lead to feeling stuck.

Ramping Up Productivity With Bulk-Bag Discharge Upgrades

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Spiroflow bulk-bag unloader: By combining hygienic bag clamps with the tensioning action of spring-loaded bag-support arms, liner distension into downstream equipment can be prevented.

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In food processing, bulk-bag discharge systems are used to transfer food ingredients such as flour, sugar, and spices from bulk bags to mixing and blending equipment.

What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies

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Photo by Lucas Vasques on Unsplash

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On Jan. 31, 2024, the U.S.

Twelve Strategies for Successful CAPA Management

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There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.

Take Out Your Customers’ Trash

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Photo by Dan Preindl on Unsplash

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‘T ake out the papers and the trash.” That was the opening line of the song “Yakety Yak” by The Coasters. It spent weeks as the No. 1 hit in 1958. Teenagers everywhere wore out their shoes dancing to the hot song.

Data Management and Reporting in FDA-Regulated Clinical Trials

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Using a single, centralized electronic data capture system helps you stay compliant and eliminates unnecessary regulatory burden. Photo by Olga Guryanova on Unsplash

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Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA).

You’ve Been Pwned!

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Photo by Anderson Schmig on Unsplash

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We take ourselves too seriously, and in doing so we become boring and no fun. Sometimes it’s OK to let loose, act silly, and have a good time. It’s energizing.

The Future Looks Bright for In-Person Networking

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Gathering in a professional setting is a boon to networking. Photo credit: Hivan Arvizu

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At a time when virtual meetings, video conferences, and online work calls are the norm, there’s good news for those who see a unique value in in-person networking.

How AI Trends Can Drive Quality Management Systems

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As the road map for AI adoption in a QMS continues to unfold, teams must stay informed about emerging technologies and trends. Photo by Possessed Photography on Unsplash

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Historically, the sensitive nature of personal and company proprietary information held in life sciences quality management systems (QMS) has been a factor for quality management teams’ reluctance to adopt AI.

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