Complaint Handling and Medical Device Reporting

Duration: 90 Minutes
Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining public safety. Complaints can 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.
Medical Device Reporting
Instructor: Susanne Manz
Product ID: 509492
Objectives of the Presentation
  • Understand regulations and expectations
  • Review enforcement case studies for lessons learned
  • Determine needed processes and procedures
  • Identify best practices
  • Understand the linkage between complaints, investigations, MDR reports, and CAPA
  • Preparing a plan for inspection readiness
Why should you Attend
Because Complaint Handling and MDRs are a critical indicator of safety issues, they are top priorities for FDA inspections. The FDA uses these as focus areas to understand if your products are performing adequately and if your Quality System is effective. Even more importantly, these are vital processes for a medical device company to ensure the health and safety of their customers.

Areas Covered
  • Overview and definitions
  • FDA expectations, regulations
  • Lessons learned and enforcement case studies
  • Processes and procedures
  • 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 can Benefit
  • Complaint Specialists and Managers
  • Individuals participating in Failure Investigations
  • Individuals analyzing returned products / Complaint Analysis
  • Regulatory Affairs
  • Quality Engineers
  • Clinical Affairs
  • R&D Engineers and Scientists
  • Compliance Specialists
  • Auditors
  • Senior Management
  • Anyone Interested in Medical Device Complaint Handling Systems
$299
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. 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 CQA (Certified Quality Auditor) from the American Society for Quality. Susanne has now established a consulting business 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.
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