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 Should Attend:
- Quality Professionals
- Regulatory Professionals
- Customer Service Professionals
- Medical Science Professionals
- Project Managers
Course Director: DR. CHRISTOPHER J. DEVINE
Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. D spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the Medical Device Summit, an e-magazine.
Furthermore, Dr. Devine has 35-years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI).
Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study. Finally, Dr. Devine is the author of five books on quality and regulatory compliance.