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Cautionary Tales

Last week on LinkedIn, I shared a recently issued FDA Warning Letter that generated a lot of views and ‘likes.’ The topic of the regulatory citation in the Warning Letter was clinical trials records retention, always a point of interest. But it seems a lot of people, not just QA and regulatory types like me, like reading FDA Warning Letters, but why? The primary reason to read them is because they offer considerable information and insight into the real world application of c

Recently Published Guidance from the FDA

There have been a number of draft and final guidance documents published by the US Food and Drug Administration (FDA) in the past several weeks. Here are several relevant to clinical research. Draft Guidance Documents: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria Guidance for Industry In this draft guidance, the FD

To Be Prepared (or Not to Be)

Earlier this week, I posted a quote about preparation and failure. While it might seem like a trite adage courtesy of Benjamin Franklin, I believe preparation is a good idea for everything from rock climbing to filing taxes. And of course, careful planning is critical to a successful clinical trial. In two previous blogs [31-Jan-18, Risk Averse? and 8-Feb-2018, The Only Thing You Have to Fear Is…], I discussed risk assessment and risk management, including the concept of risk

Knock, Knock

I often emphasize that the FDA website has a wealth of publicly available information related to regulatory compliance, clinical research and development, ethics and human subjects’ protection, along with many other relevant topics. Today, I’d like to open the door to just one category of these valuable resources. The FDA wants to help people understand the regulatory requirements related to developing, evaluating, submitting and gaining approval for new medical devices, phar


Two seemingly unrelated bits of information converged this week to put me in a reflective mood about how I have seen quality assurance and regulatory compliance change in many positive ways over the course of my career. The first was an excellent SQA sponsored webinar from last November that I caught up with listening to on line. The presentation was titled, ‘Tactical Questioning’ and was delivered by retired FBI Agent William Vincent. It was a fascinating review of the effec

The GCP Compliance Photo Album

I have been asked to provide ‘inspection readiness’ training many times. And while it’s tempting to do it with just one slide, more detailed content such as understanding the inspection process, practical tips about what to do and what not to do, and some insights into what I call the ‘auditor brain’ can help those who may be involved in inspections feel more confident (but not too confident), including both experienced and inexperienced staff at clinical investigator study s

Put Yourself in the Driver's Seat

A colleague and I were recently sharing QA ‘war stories.’ She was relating to me her encounter with a, ‘But why?’ person in the GCP operations world. These are the folks who demand you point to ‘the specific regulation that says we have to have SOPs.’ After many years working in clinical research and development, there is nothing I would like more than GCP regulations that provide as many clear-cut requirements as GLP and GMP regulations seem to do. But alas, wishing has not

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