Those things that form quickly and set up like cement. The blind spots of not really knowing the impression you leave on others. You think you are having a conversation, or making a post on social media – but there it is – opinions are formed about you instantly. Continue reading
Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding risk based approaches to clinical research. These documents include FDA’s “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and EMA’s “Reflection paper on risk based quality management in clinical trials”. Continue reading 
If you are reviewing a drawing or set of specifications and all the tolerances are set at a blanket value, this should raise your suspicions, for it implies that every tolerance has the same importance as all others. This may be true, yet it is often not possible nor necessary for the design and resulting system to function correctly. Continue reading
I was thinking…if only telepathy were a viable means of communication rather than being told that I had been sent an email, along with several dozen others! Continue reading
Many CRO’s come from compliance, legal, or finance areas. They do not know operations or quality. This person is critical to quality‘s success with ISO 9001:2015 in terms of providing risk approvals, direction, and resources. The quality department should be flexible and work with the CRO, specifically: Continue reading