Medical Device Complaint Management System – Webinar Recording/Transcript
Medical Device Complaint Management System: Addressing Complaints Effectively
The best way to prevent problems in patient safety, customer satisfaction and regulatory compliance is to have a solid complaint management system in place. Being able to thoroughly investigate complaints and identify corrective and preventive actions (CAPAs) in a timely manner also helps you with navigating regulations from U.S. and EU agencies.
Your complaint management system should have measurable key indicators — timeliness of investigations, recurrence of complaints and trends of complaints — to provide you with critical insights and quality products.
Join Allison Fulton, partner at Sheppard Mullin, for a discussion on establishing strong complaint management processes.
Key Presentation Takeaways:
- Determine regulatory requirements for an effective complaint management system
- Evaluate trends in regulatory enforcement on complaint handling
- Assess the importance of consistent complaint intake in measuring effectiveness
- Measure the effectiveness of a complaint handling system
- Audit the complaint system
- Identify tips for conducting robust complaint investigations
- Address special topics, such as what to do when the product is not returned
A strong complaint management system allows you to make continuous improvements in patient safety, customer satisfaction and regulatory compliance.
Meet Your Presenter:
Allison Fulton, Partner, Life Sciences and FDA team, Sheppard Mullin
Your webinar leader is Allison Fulton, partner at Sheppard Mullin in Washington, DC. She helps life sciences companies (including pharmaceutical, medical devices and dietary supplements) in matters relating to the development, manufacture and marketing of products regulated by the FDA. Ms. Fulton’s areas of focus include assisting US and global companies in complying with premarket and postmarket FDA requirements such as marketing authorization, clinical trials, compliance with GxP, product promotion and labeling, recalls and other product safety issues. She regularly advises companies on preparing for FDA inspections, responding to FDA Form 483s and warning letters, remediating GMP and data integrity issues and handling adverse events and medical device reports (MDRs).
Who Will Benefit:
- Regulatory affairs personnel
- Compliance personnel
- Quality affairs personnel
- Legal personnel