As we watch athletes compete in the Winter Olympics, from Alpine skiing to bobsledding, the line between peak performance and physical risk is small. In 2026, technology is not just a training aid; it’s now a...
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I “DO” change leadership. I am a proud change agent. I have led many change initiatives, from Quality Management System updates to Merger and Acquisition teams. I have read the change theories, studied the books,...
Read MoreIt’s 1995 and I am excited to be in my first team meeting, leading the implementation of not only ISO 13485, but the new Quality System Regulation! I’ve read everything I can read about what...
Read MoreA warning letter published on July 19th, 2022 by the FDA to Young Living Essential Oils names not only the company but also individual consultants within its multi-level marketing organization (find it below). The FDA...
Read MoreEvery successful business has a reason for existence, a long-term mission/vision, and corresponding goals. The bridge between the Mission/Vision and the business goals is the business strategy. Strategy is commonly defined as a plan of...
Read MoreIt happens at least a few times a year as I interface with pharma/bio/med tech clients. We start talking about computerized system use or data integrity of records, and I invariably hear some version of:...
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