Transferring A Medical OEM Molding or Assembly Operation to A World Class Contract Manufacturer With FULL Validated Systems And Processes
11th October 2012 — 12th October 2012
This Medical device interactive seminar will provide valuable assistance in developing a gap analysis to either transfer a molding operation or a product line to a World Class Contract Manufacturer.
This Medical device interactive seminar will provide valuable assistance in developing a gap analysis to either transfer a molding operation or a product line to a World Class Contract Manufacturer. It will give a process and procedure for transferring a whole operation or equipment, products, molds, dies, systems and processes to suppliers. It will show how quality, engineering and operations can work together to meet today's standards for authorizing bodies.
The medical industry is in transition. OEM's are in the process of transferring more product and operations to contract manufacturers. Some OEM's and contract manufacturers are struggling with how to deal with these transfers and validation standards.
Are you prepared?
Bring your transfer plans, ideas and questions to an interactive workshop and seminar where you can discuss your plans and learn how others of successfully transferred medical molding and products.
This successful case study will guide you in the procedures and process of transferring operations, product, equipment, tools or processes to meet the evolving standards for the medical industry. With the regulations for quality and validations getting more stringent with every transfer, it is imperative that companies are armed with the skills to plan and execute equipment, tools and process transfers properly. This is a step by step process to guide you in your transfer. It will follow a recent successful case study in the medical industry.
Areas Covered in the Two Day Interactive Seminar:
Half day workshop to help the participants develop an plan action to take back with them for future transfers
- Gathering of data for a gap analysis
- Performing a gap analysis to see if a transfer is appropriate
- Choosing the right World Class Contract Manufacturer
- What procedures need to be in place to transfer equipment and processes to another facility in-house or to a contract manufacturer
- How to choose the right “World Class” quality supplier
- Developing a Master Validation Plan
- Developing Quality Plan
- Risk management
- Validations and quality procedures
Senior management, Strategic management, OEM plant managers and operation personnel in the medical industry, R&D, product development engineers and managers, QA, Regulatory Affairs
Expected Number of Attendees
Price of Attendance
(Venue to be announced shortly)