Effective Complaint Handling & Medical Device Reporting 2016

Topics

• 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

Who should Attend

• 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