FDA Quality System Regulation & Preamble - Reference Guide
From the pages of "The Silver Sheet"
Prepare for your next FDA inspection with the Quality System Regulation and Preamble, available exclusively from Elsevier Business Intelligence. It’s the only guide anywhere that includes both the regulation plus its preamble, FDA’s elaboration on the regulation that was published along with the QSR in 1996.
If you want to avoid costly and time-consuming FDA compliance problems, then you’ll want this guide – an essential tool for all quality and regulatory professionals!
Confidently handle your next FDA inspection with this essential tool for quality and regulatory professionals. This guide contains the complete text of the Quality System Regulation establishing GMP standards for medical devices, plus the full preamble explaining FDA’s expectations. Brought to you by “The Silver Sheet,” this is an indispensable resource for anyone involved in medical device manufacturing.
"The Silver Sheet" is the only publication where you will find in-depth analysis of quality control and compliance issues for the medical device and diagnostic industries. It provides critical updates on FDA’s interpretation and enforcement of Quality System Regulation, interviews with top FDA compliance officials, the latest news on inspections and warning letters, plus coverage of recalls, enforcement actions, international quality standards, and more.
Be certain that you understand the nuances of FDA’s continually evolving compliance regime, improve your quality systems and reduce costs, avoid disastrous inspection results, stay on top of trends in recalls and warning letters, adopt new best practices, and control manufacturing processes in an unpredictable regulatory environment. Ensure all of this with “The Silver Sheet”.