Spotlight on Complaint Handling and Medical Device Reporting
Instructor:
Susanne Manz
Product ID: 706099
- Duration: 90 Min
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
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.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
