Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities 2018

Topics

• Medical Device and Drug Complaint Handling Requirements (US)
• Complaint Definition and Sources
• Reportable Events
• Interrelationship of Complaint Handling, CAPA, Change Control, Adverse Event Reporting and Recalls
• What in Itself is a Reportable Event
• When Does a Complaint Become a Reportable Adverse Event
• Voluntary and Mandatory Reports, and Reporting Timelines
• How Does User Error Relate to Adverse Event Reporting
• What May Trigger a Recall During the Complaint Investigation
• Complaint Handling Life-Cycle Process (including an example that embraces activities related to above five bullet points)
• Challenges
• Recall Classifications
• References
• Conclusion

Who should Attend

• Quality Assurance Departments
• Regulatory Affairs Departments
• Compliance Departments
• Quality Control Departments
• Complaint Handling Departments
• Manufacturing Departments
• Operations Departments
• Engineering Departments
• Process Development Personnel
• Design Engineers
• Customer Service Personnel
• Service Technicians and Engineers
• Sales Representatives