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Complaint Handling and Medical Device Reporting
- 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
Overview of the webinar
Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical they are the frequently inspected areas 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. Complaint management and MDRs are critical quality systems to your 3 key stakeholders – the customer, the regulators, and your business.
Who should attend?
- 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
Why should you attend?
- 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
Faculty - Miss.Susanne Manz
Susanne Manz 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. She 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 Certified Quality Auditor (CQA) certification 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.