Complaints, Servicing and FDA Reporting 2017

Topics

• Among 30 day reports, 5 day reports, and supplemental reports
• When a complaint should be reported as an MDR
• When field actions must be reported to the FDA
• The required records for field actions involving changes to a medical device
• The required records for servicing
• How a remedial action in an MDR relates to Corrections Removals reporting
• The systems for statistical analysis of service reports and for complaints

Who should Attend

• Quality Managers
• Quality Engineers
• Regulatory Managers
• Regulatory Specialists
• CAPA Specialists
• Compliance Specialists
• Service Engineers
• Sales Managers
• Service Managers
• Service Supervisors
• Design Engineers
• Manufacturing Engineers
• Engineers involved in developing Field Modifications
• Engineers involved in managing Design Changes