Medical Device 2012 - Transferring a Medical OEM Molding and Assembly Operation to a Manufacturer With Validated Systems and Processes

Learn from successful case studies on how to Transfer a Medical OEM Molding Operation to a world class molder and Transferring an Assembly Operation from one OEM supplier to another manufacturer with Validated Systems and Processes.

This 2-day seminar will provide valuable assistance and give a process and procedure to all regulated companies that are transferring equipment, molds, dies, systems and processes to suppliers. It will show how quality, verifications and validations process will meet today’s standards for the FDA and CE Mark.

Areas Covered:
- What procedures need to be in place to transfer equipment and processes to another facility in-house or to a supplier
- Developing a Master Validation Plan
- Developing Quality Plan
- Gathering of data for a gap analysis
- Risk management
- Validations and quality procedures
- How to chose the right “World Class” quality supplier
- The transfer plan
- The equipment transfer
- The tool transfer
- The assembly transfer
- Validations and quality procedures
- Multi-functional team approach/responsibility
- Operations, quality and validations
- Pit falls and downsides
- Conduct a “Lessons Learned Program”