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Last week, I touched on the idea of involving and empowering all employees in the workplace through the corrective ...
The pandemic has been a challenging time for all industries including the Food and Drug Administration (FDA). The ...
At one point or another, you likely took care of a non-conformance within your operations. Non-conformances in ...
Following are some popular views about the cars mentioned related to quality management systems, above. Substitute ...
No matter what our perspectives may be or how they may differ, time is the one thing money cannot buy. It matters ...
Studies are indicating the increasing use of electronic nicotine delivery systems (‘ENDS’) products, particularly ...
Clinical trials, when conducted with great care, are the safest and fastest way in having a treatment approved for ...
It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen ...
A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to ...
What makes teams successful, based upon a study of employees working within process improvement teams for each of ...
Coronavirus (COVID-19) has been prevalent in the United States for over 2 years, on July 6th, the Food and Drug ...
If you are a drug manufacturer in the US, an Annual Drug Product Review (ADPR) should be familiar to you. ADPRs ...
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