Spotlight on Complaint Handling and Medical Device Reporting

Instructor: Susanne Manz
Product ID: 706099
  • Duration: 90 Min
This webinar will help you to understand the expectations of complaint handling and medical device reporting. You’ll also learn about lessons from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage complaints and MDRs. Also, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action). We’ll cover best practices, so you can be prepared for an FDA inspection.
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Why Should You Attend:

Complaint management and Medical Device Reporting (MDR) are critical quality systems for a medical device company to meet the needs of its 3 key stakeholders – the customer, the regulators, and your business. They are considered critical processes by the FDA in maintaining public safety. Because they are so critical they are frequently inspected by the FDA. More importantly, complaints can also be an early warning of issues with your products and customer problems. It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. This webinar will cover the basics of complaint management and medical device reporting.

Areas Covered in the Webinar:

  • Overview and Definitions
  • FDA Expectations, Regulations
  • Lessons Learned and Enforcement Case Studies
  • Processes and Procedures
  • Flow Chart
  • Reportability Criteria
  • Investigating a complaint or MDR
  • Linkages between Complaint Handling, MDRs, and CAPA
  • Common Mistakes and how to avoid them
  • Best Practices
  • Preparing for an FDA or NB Inspection

Who Will Benefit:

  • Complaint Specialists and Managers
  • Individuals participating in Failure Investigations
  • Individuals analyzing returned products / Complaint Analysis
  • Regulatory Affairs
  • Quality Engineers
  • Clinical Affairs
  • Complaint Handling Unit Personnel
  • Compliance Specialists
Instructor Profile:
Susanne Manz

Susanne Manz
President and Principal Consultant, Manz Consulting Inc

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

Follow us :
Risk Management in Medical Devices Industry
Managing Your Complaints and Obstacles in Post-Market Requirements

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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