Implementing Medical Device Complaint Handling Systems 2012

Topics

• Definitions
• The applicable 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)
• Lessons learned
• Enforcement actions: numerous case studies

Who should Attend

• VPs
• CEOs
• Attorneys
• Compliance officers
• Clinical affairs
• Complaint handling personnel
• Quality assurance
• Regulatory affairs
• CROs
• R&D
• Contractors/subcontractors
• Consultants