Essentials of Complaint Handling and Medical Device Reporting 2017 is a webinar that covers topics such as:
- FDA Expectations, Regulations
- Overview and Definitions
- Processes and Procedures
- Lessons Learned and Enforcement Case Studies
- Investigating a complaint or MDR
- Reportability Criteria
- Common Mistakes and how to avoid them
- Linkages between Complaint Handling, MDRs, and CAPA
- Preparing for an FDA or NB Inspection
- Best Practices
Essentials of Complaint Handling and Medical Device Reporting 2017 is intended for:
- Individuals participating in Failure Investigations
- Complaint Specialists and Managers
- Regulatory Affairs
- Individuals analyzing returned products / Complaint Analysis
- Clinical Affairs
- Quality Engineers
- Compliance Specialists
- Complaint Handling Unit Personnel
