The Complaint Handling Requirements Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities 2018 is a webinar that covers topics such as:
- 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
The Complaint Handling Requirements Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities 2018 is intended for:
- 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
