Lack of an effective complaint management system is a frequent Form 483 observations cited during FDA 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 this webinar will provide valuable tools for optimizing 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 is no such thing 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 Covered in the Session :
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
Medical Device Reports (MDRs)
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