As of February 2, 2026, the medical device industry officially entered a new regulatory era. The long-anticipated transition is complete: the Quality Management System Regulation (QMSR) has modernized 21 CFR Part 820 by integrating ISO...
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We recently completed a workshop on How a GLP facility can go digital in a compliant manner at a large multinational company. The 3-day workshop, led by Jackie Torfin and Brendan Hyland, started with a...
Read MoreDoes this seem familiar? In a small company called Inept Inc., a well-intentioned but misguided manager named Mr. Fumble, a man with an undeniable charm that often eclipsed his incompetence, surrounded himself with a team...
Read MoreI “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...
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