Current Good Manufacturing Practice for Medical Devices Including IVDs 2013

Key Topics

• Flexibility of the QSRs
• Overview and review of the US QSRs for medical devices
• Quality system requirements
• Definitions
• Audits
• Management responsibility
• Design control
• Personnel
• Design history file (DHF) and device master record (DMR)
• Validation, design transfer, and design changes
• Purchasing controls
• Quality system procedures
• Process validation
• Inspection, measuring and test equipment
• Complaint files
• Corrective and preventive action (CAPA)
• Quality requirements for premarket approval (PMA) application
• Servicing
• Lessons learned
• Enforcement actions: case studies

Who should Attend

VPs, CEOs, Attorneys, Compliance officers, Regulatory affairs, Clinical affairs, R&D, Quality assurance, Consultants, CROs and Contractors/subcontractors.