"Every 483 Observation Has A Training Component"
“Every 483 observation has a training component.” Truer words have never been spoken—I only wish it was me who said them. An FDA inspector I heard at a conference almost 15 years ago made this statement, and it forever changed how I look at 483 observations. I’ll admit up front that I have a bias towards training—after all, it’s what I do. Others don’t necessarily share that bias, being that often training isn’t done well, isn’t timely or effective, isn’t always meaningful. I’ve heard the arguments and can even agree with some of them. But let’s set that aside for now and look at what the inspector meant.
WHITE PAPERS & CASE STUDIES
Exceeding GMP Of Medical Devices At Each Step In The Production Continuum
Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.
Don’t Get Blindsided By New USP Quality Standards
The U.S. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years – and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December 2013. By Dirk Ahlbrecht, Sartorius Group
Points To Consider When Developing A TMF (Trial Master File) Strategy
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). By Karen Redding, Global Business Development Director, Phlexglobal Ltd.
3 Tips For Safe, Secure Healthcare Shipping
All businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical
Using Collaborative Review And Authoring Technology Increases Productivity And Drives Value Across The Company
Conatus Pharmaceuticals Inc. is headquartered in San Diego, California and is a privately-held biotechnology company focused on the development of human therapeutics to treat liver disease and cancer. Currently, the company’s primary activity is based on the clinical trials for the treatment of Hepatitis C Virus.
Secure & Enforceable: The DocuSign Electronic Signature
This paper describes the DocuSign electronic signature in the context of state, federal and international standards for legal and enforceable electronic signatures.
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LIFE SCIENCE WEBINARS
Aseptic Management of the Sterility Testing Process
Get the latest information on the aseptic management of the sterility testing process and find out some key insights into best practices.
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This webinar is about overcoming analytical method development challenges with analysis of nonclinical dose formulations from hERG studies.
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In this webinar you will learn about delivering intravenous-dosed biologics in an aseptically-filled intravenous bag and increase your understanding of the business drivers and potential value added with this strategy.