Product Details
Handling nonconforming products is one of the device industry's biggest headaches.
Complying with FDA rules in the Quality Systems Regulation and international standards in ISO 13485 requires an almost Holmesian ability to dig out information and make accurate deductions. Definitions are not clear, and requirements are scattered throughout regulations. In addition, nonconforming product management has major implications for device history records and CAPA. This management report, based on a presentation by device systems expert Dan O'Leary, does the sleuthing and deducing for you. Pertinent regulatory passages are pulled out, interpreted and illustrated with examples from actual FDA warning letters. You'll learn:
Order Your Copy Today!
|
Available Format
Who Will Benefit
Multi-user AccessSave money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library – a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information. Our GuaranteeNot satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price. |