"The Silver Sheet"

"The Silver Sheet"

“The Silver Sheet” is a monthly publication delivering an in-depth analysis of quality control and compliance issues for the device and diagnostic industries. “The Silver Sheet” provides important updates on international standards, FDA’s interpretation and enforcement of Quality System Regulation, detailed summaries about FDA warning letters and recalls, compliance and pre- and post-market issues, and more.

See for yourself what makes “The Silver Sheet” the industry's premier intelligence resource on medical device quality control. Consider the following insight regarding FDA warning letters:

• Prevention is a company’s most cost-effective defense against FDA warning letters. “By the time a warning letter goes out the door, a company likely already has a problem, so it really should get on top of it before then,” says new CDRH director.
• Quality audits by the FDA show companies often don’t follow their own established procedures. Find out which FDA violations [via warning letters] are becoming prominent, and why.
• Your geographic location can impact how likely you are to get a warning letter. “The Silver Sheet” parsed FDA records to develop data showing which offices send the most warning letters.

“The Silver Sheet” will help you understand FDA regulations, improve compliance and reduce costs, stay on top of trends in recalls and warning letters, improve your supply chain, adopt new best practices, avoid disastrous inspection results, and control manufacturing processes in an increasingly unpredictable environment… among many other benefits.

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©2013 Elsevier, Inc. Medtech Insight is owned by Elsevier Business Intelligence. All rights reserved. No part of this publication may be reproduced in any form or incorporated into any information retrieval system without the written permission of the copyright owner. Editors report information from reliable sources and do not assume liability for information published. Subscription Terms.