Complaint Handling Requirements - Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities 2015

The Complaint Handling Requirements - Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities 2015 is a webinar dedicated to the regulatory requirements (US) for complaint handling in the Medical Device and Pharmaceutic.

Key Topics

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

Who should Attend

Senior attendees with responsibilities in:

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