Course offering number:0811-108
Course ID:
1834
Complaint Handling and MDR Reporting
November 3-5, 2008
New Brunswick, NJ
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
- Management of the System
- Receiving and Documenting Complaints
- Investigating Complaints
- Regulatory Compliance
- MDR Reporting
- Product Performance Monitoring
- Internal Auditing
- Training
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-by-step 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