Establishing a Medical Device Complaint Handling System integrated with a UDI System 2014 is a webinar that covers topics such as:
- Definitions
- Statutes and regulations
- How to process complaints
- What to do when complaints are received?
- When to investigate complaints
- What processes need to be in place?
- Contents of records of investigation
- When to open a CAPA(s)
- Good practices: suggestions and recommendations
- Unique device identification/identifier (UDI) integration
- Lessons learned
Establishing a Medical Device Complaint Handling System integrated with a UDI System 2014 is intended for:
- VPs
- CEOs
- Attorneys
- Compliance officers
- Clinical affairs (associates, specialists, managers, directors or VPs)
- Complaint handling personnel
- Quality assurance (associates, specialists, managers, directors or VPs)
- Regulatory affairs (associates, specialists, managers, directors or VPs)
- CROs
- R&D (engineers, scientists, managers, directors or VPs)
- Contractors/subcontractors
- Consultants
- Anyone involved in the clinical trials or studies
