Transferring a Medical OEM Molding and Assembly Operation to a Manufacturer With Validated Systems and Processes 2013

Key Topics

• Developing a Master Validation Plan
• Procedures to transfer equipment and processes to another facility in-house or to a supplier
• Gathering of data for a gap analysis
• Developing Quality Plan
• Validations and quality procedures
• Risk management
• The transfer plan: The tool transfer, The equipment transfer and The assembly transfer
• Choose the right "World Class" quality supplier
• Multi-functional team approach/responsibility
• Validations and quality procedures
• Pit falls and downsides
• Operations, quality and validations
• Conduct a "Lessons Learned Program"

Who should Attend

• Manufacturing engineers
• OEM plant managers and operation personnel in the medical industry
• QA, Regulatory Affairs and validation teams
• R&D, product development engineers and managers associated with validation of new products
• Senior management
• Validation specialists
• Suppliers to the medical industry
• Suppliers entering into the medical industry
• Corporate auditors
• Consultants