March 3, 2020
Data drives the pharmaceutical and medical device industries. It informs the manufacture and release of medical products to patients and consumers, and determines which products are approved for sale in the US and other markets. And regulators, like the FDA, rely on data to determine whether a manufacturing operation is compliant with cGMP and QSR […]
January 2, 2020
Well-drafted, easy-to-understand quality records are crucial to helping pharmaceutical and medical device manufacturers navigate FDA inspection obstacles. The FDA relies heavily on information presented in inspection-ready documents to determine whether a manufacturing operation is compliant with FDA’s requirements and expectations, as expressed (in theory) in a company’s own SOPs. But investigators won’t put in herculean […]
September 5, 2019
Are you a device or combination products manufacturer or service provider? 21 CFR 820 Connected to ISO 13485 AAMI has just released an important document mapping US 21CFR 820 to the Medical Device Standard ISO 13485. Suppose you have not started or are behind in your harmonization efforts. In that case, I strongly urge a […]
August 28, 2019
FDA inspection risk management is an essential activity for regulatory compliance within pharmaceutical and medical device companies. While it is often challenging for medical product manufacturers to incorporate risk-based principles into their quality and compliance approaches, it is essential that compliance-implicated documents are drafted in a way that considers risk principles to facilitate FDA reviews […]
August 21, 2019
After decades in the pharma, device, and biologics industry working in new product development and manufacturing quality; market quality and post market surveillance; and quality systems my answer can be summed up in one word. Watermelon. yes, watermelon. Why watermelon? Today’s drive to measure, measure, measure has yielded a culture of creating metrics that will […]
April 22, 2019
By now, most everyone in FDA regulated industry is aware of Theranos, the Wall Street Journal’s John Carryrou, and his award-winning book Bad Blood: Secrets and Lies Inside a Silicon Valley Startup. But have you seen HBO’s new documentary, “The Inventor: Out for Blood in Silicon Valley?” I was lucky enough to come across the […]
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