Complaint Handling and MDR Reporting
December 07 - 09, 2009
New Brunswick, NJ
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Who Should Attend
This practical program will be of benefit to all medical device
personnel involved with their company's Complaint Handling
Systems including personnel responsible for the following:
• Implementation of the System
• Receiving and Documenting Complaints
• Regulatory Compliance
• Product Performance Monitoring
• Training
• Corrective and Preventive Action
• Management of the System
• Investigating Complaints
• MDR Reporting
• Internal Auditing
• Failure Investigation
Description
Complaint handling systems have come under intense scrutiny
by the FDA in recent years. This course will examine the
current industry FDA environment and seek to provide you
with knowledge and tools for survival. It will provide a step-bystep
guide to the setting-up, operation, management and
auditing of a Complaint Handling System for today's medical
device industry environment.
There will be case studies in which various examples of
complaint systems will be presented. Pragmatic, simple,
statistical trend methods will be reviewed and attendees will
utilize what they learn in a series of workshops.
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