Managing Nonconforming Product: A Devicemaker’s Guide to Compliance
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:
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