A 300% increase in anything gets attention, however, when it is a “rule governing medicinal product in the European Union” it demands attention and action (EudraLex – Volume 4 (europa.eu)). Annex 1 which is the guide for the “Manufacture of Sterile Medicinal Products” (20220825_gmp-an1_en_0.pdf (europa.eu)) was just released on 22 August 2022. This document is […]
In-person conferences continue to emerge as evidenced by the recent “GMP by the Sea” held on August 15, 16, 17th in Cambridge, MD. A well balanced conference, led by regulatory leaders, provided relevant “look backs” as well as prospective “look forwards” giving attendees a collective perspective of learning from the past as well as a […]
“Leaders win through logistics. Vision, sure. Strategy, yes. But when you go to war, you need to have both toilet paper and bullets at the right place at the right time. In other words, you must win through superior logistics.” (Tom Peters – Rule #3: Leadership Is Confusing As Hell, Fast Company, March 2001), from […]
“At the end of a wrench, is a patient.” The tragic events that happened twelve years ago aboard the Deep Water Horizon (yes, the one that the movie was based on) reinforced a sacred rule – accountability cannot be outsourced. For those who are not aware, of the approximately 126 personnel on board, only 7 […]
The creation, tracking, and publication of quality metrics has long been a source of sensitivity and confusion. People may fear them because they feel that they don’t tell the whole story or that they may invite criticism and misinterpretation. Thus, quality metrics were held tightly close to the chest of business leaders. Deming identified this […]
