December 7, 2020
Quality culture can be extremely difficult to measure quantitatively…especially for companies regulated by the FDA. In this video, CEO Jack Garvey explains how organizations can begin to quantify their “quality culture” in an effort to benchmark and improve performance. People know, kind-of, qualitatively, what a company’s culture is, but that, thumb-in-the-air, “Yeah, I think they’ve […]
November 23, 2020
I love risk, and FDA risk management is something I live in every single day. I think it’s really important to understand that when people talk about risk and FDA risk management, it’s not about the elimination of all risk. It’s almost impossible to eliminate all risk. We get out of bed each day, and […]
September 16, 2020
Guidance Inartfully Mixes New and Old Expectations – Creates Confusion for Drug and Biologics Manufacturers As the COVID-19 pandemic continues, FDA continues its efforts to steward public health decision-making in an increasingly challenging regulatory climate. FDA’s most recent guidance for drug and biologics manufacturers was released late last week. The new compliant-manufacturing resumption guidance covers […]
May 5, 2020
For life science manufacturers concerned about third-party access to facilities, we have been recommending they add pre-entrance gowning to existing gowning procedures and extend the gowning envelope to the building exterior. This can be accomplished through an expedited change control – and should incorporate risk-based considerations. Objectives & Principles for Leveraging Expedited Change Control The […]
April 17, 2020
Navigating the challenges of staffing within FDA-regulated companies requires strategic considerations to avoid setbacks and maintain operational excellence. From the opportunity costs associated with internal resource swapping to the necessity of filling new or rebuilt roles effectively, executives face critical decisions that impact compliance and productivity. By leveraging executive placement firms, companies can mitigate risks […]
March 27, 2020
The FDA has long taken a risk-based approach to manufacturer GMP compliance expectations and enforcement actions, as well as requiring pharmaceutical and medical device manufacturers to do the same in their quality system operations. Similarly, companies can also use risk management approaches to rapidly reduce organizational risk in their data integrity efforts, by directing their […]
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