Effective Complaint Handling & Medical Device Reporting 2016 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
Effective Complaint Handling & Medical Device Reporting 2016 is intended for:
- Complaint Handling Unit Personnel
- Complaint Specialists and Managers
- Individuals participating in Failure Investigations
- Auditors
- Regulatory Affairs
- Individuals analyzing returned products / Complaint Analysis
- Clinical Affairs
- Quality Engineers
- Compliance Specialists
- R&D engineers and scientists
