Complaint Handling and Medical Device Reporting
- Speaker:Susanne Manz
- Product Code:GRC-90362
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Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical the FDA frequently inspects these areas in great detail. More importantly, complaints can be 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.
- 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
Topics We Will Be Covering:
- 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
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, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance.
Susanne 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.