Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities “on Wednesday Oct 27, 2021 03:00PM Duration: 90 Minutes.

Register Now     

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)
Interrelationship of complaint handling, CAPA, change control, adverse event reporting and recalls
Complaint sources
What may trigger a recall during the complaint investigation
Complaint handling life-cycle process (including an example that embraces activities related to bullet four, above)
Challenges