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.
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
