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Device Complaint Management: Pass Inspection Without Getting a 483
Come up short in an inspection and the FDA can issue a Form 483 or a warning letter.
But that does not have to be the case if you include the four major elements in your device complaint management system:
Using FDA sources such as regulations, the QSR preamble and inspection techniques, industry expert Dan O’Leary will explain each of those topics and show you how they link together while providing advice on effective implementation.
This webinar provides the practical information you need so that your device complaint management system passes an FDA inspection without a 483. In 90 minutes you will learn:
Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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