Establishing a Medical Device Complaint Handling System integrated with a UDI System 2014

Topics

• 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

Who should Attend

• 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