May 15, 2025
A Quality Professional’s Perspective on Why Change Management Efforts Fail When you get to the point of your career I now find myself in, you will have seen many change management efforts falter or fail. While some common themes and pitfalls contribute to all such failures, I want to emphasize those that I think are […]
May 14, 2025
“Quality is never an accident; it is always the result of Intelligent effort.” …John Ruskin I have spent the last 20+ years in the biopharmaceutical industry. My journey began modestly, starting with washing lab glassware, researching, and working as a QC environmental monitoring sampler. From there, I advanced to line supervisor and lab manager roles, […]
May 14, 2025
Aristotle once said, “Quality is not an act; it’s a habit.” This is the first in a series of articles on Quality Culture in the Medical Device Industry. In this first article, we focus on the unique challenges we face in creating a strong quality culture in the medical device industry and considerations for the […]
May 8, 2025
“How did you go bankrupt?” Bill asked. “Two ways,” Mike said. “Gradually and then suddenly.” -Ernest Hemingway, The Sun Also Rises. Gradually, Then Suddenly In Ernest Hemingway’s novel “The Sun Also Rises,” the quote above refers to the character’s financial predicament. However, most of us can see that this sentiment resonates far beyond financial matters and […]
May 8, 2025
The following article is a transcript from the “How is Quality Pulse different from other tools on the market?” video with Teresa, Kenneth, and Jerry. Jerry Appert: Great, great discussion. When you think about all of the different applications and use cases that you both articulated so nicely, maybe one of the questions I started […]
May 8, 2025
The Quality Pulse® culture diagnostic tool is appropriate for all companies in biopharma and pharma, in regulated consumer products, in devices, and in combination products. Companies that do not have a culture supportive of enabling quality…they suffer poor health authority outcomes, there is a lack of trust amongst healthcare providers and patients, there are unplanned […]
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