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Managing Medical Device Complaints
Complaint management is one of the most frequently cited QSR violations in warning letters.
An effective complaint management system must be compliant with several requirements including:
Manufacturers need to establish top-rung complaint procedures as well as creating records and documents that ensure smoothly functioning QMS along with FDA compliance.
Join industry expert Dan O’Leary for an in-depth review and analysis of FDA inspection techniques, QSIT and warning letters.
He will provide practical, real-world tips on the:
Order today for a concrete understanding of how complaint files are managed across both domestic and international facilities.
Creating the procedures, developing the records, and ensuring compliance is a team effort involving many functions and disciplines. This includes people in the following roles:
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 ofexperience 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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