March 3, 2021
Quality Pulse® has several use cases which it adds value to an organization. I’ll give 4 as an example, here. 1st occurs very often, a company is undertaking a quality systems improvement initiative in which they are revising their procedures and systems. It may be driven by a regulatory audit, an internal audit, continuous improvement, […]
February 15, 2021
The Quality Pulse® diagnostic tool is a tool that helps an organization understand three things, really… So, it’s really about a couple of things. One is, what is management say when they talk? The second thing is, do they “walk-the-talk?” And the third thing is really, how well do the systems and processes for reward […]
January 14, 2021
I’ve read a lot of Warning Letters in my 30 years of working in FDA-regulated industry. But one issued this week made me stop and think: is the FDA getting blunter in its language? Warning Letter & Response The Warning Letter was issued by FDA’s Office of Pharmaceutical Quality Operations to a Florida-based OTC manufacturer […]
January 13, 2021
Quality culture has been something that has been really hard to create tight, and kind of, geometric bounds around. But, in fact, it’s something that’s critically important for industry to understand how to essentially establish a measure of culture…because you really need to know where you are, such that you can achieve where you want […]
December 22, 2020
Now that the dust has settled from FDLI’s Enforcement, Litigation, and Compliance Conference and everyone is back to the new normal (Zoom calls, casual clothes and longer hours) we’ve had time to process our highlights from this great event. The conference highlighted insights from FDA Regulations and Insutry Trends. We’re proud to have once again […]
December 9, 2020
Carmody Quality Solutions Collaboration Carmody Quality Solutions, LLC (CQS), a consulting partner that provides quality management services to the pharmaceutical industry, announced a first-of-its-kind eBook that helps quality and compliance professionals develop a Voluntary Quality Assurance (VQA)® Culture The eBook “The Science And Art of Building a VQA Culture” includes a preview of Compliance Architects’ […]
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