2019 - Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

Complaint definition
Medical device and drug complaint handling requirements (US)
Complaint sources
Interrelationship of complaint handling, CAPA, change control, adverse event reporting and recalls
Reportable events: when does a complaint become a reportable adverse event; what in itself is a reportable event; how does user error relate to adverse event reporting; voluntary and mandatory reports, and reporting timelines
What may trigger a recall during the complaint investigation
Recall classifications
Complaint handling life-cycle process (including an example that embraces activities related to bullet four, above)
Challenges
Conclusion
References