Lack of an effective complaint management system is one of the more frequent Form 483 observations cited during FDA device establishment inspections. In fact, failure to process complaints in a timely and uniform manner will quickly lead to other Quality Management System issues such as late Medical Device Reports (MDRs) or the potential to completely miss an opportunity to file an MDR for a serious adverse event.
If your organization is struggling with an overly burdensome complaint management system or the number of complaints is continuing to rise with no end in sight, then now would be a good opportunity to streamline your organization’s approach to complaint management.
This Webinar will breakdown the complaint management process so attendees will be exposed to a clear, concise and compliant approach to complaint management in accordance with 21 CFR, Part 820.198 requirements. Remember, there are no such things as maximum compliance or minimum compliance; there is just compliance when it comes to meeting the FDA’s requirements for the complaint management system.
Areas to be Covered:
Reviewing the Requirements Associated with 21 CFR, Part 820.198
Understanding the agency’s interpretation of processing complaints in a timely and uniform manner.
Information that needs to be incorporated into a complaint file.
The complaint investigative process.
Processing oral complaints.
Use of decision trees to determine the need to report a complaint as an MDR reportable event.
The documentation process for when a decision is made not to investigate a complaint.
Customer response letters and follow-up.
Linkage to the CAPA System
Who will Benefit:
Customer Service Professionals
Medical Science Professionals