This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
Why Should You Attend:
The session will include requirements for complaint files and key requirements of:
Complaint procedures
Investigations
What to document when it is determined that an investigation is not needed
What actions are required if a complaint represents a reportable event
Record retention
Areas Covered in the Webinar:
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)
Attend Live Webinar
Apr 13, 2021 - 03:00 PM EST
Duration: 90 Minutes