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.
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
Course Provider
Susanne Manz,
