Decommissioning a Medical OEM Molding Operation and Transferring to a Contract Manufacturer

This webinar will provide processes and procedures to all medical device companies that are thinking of transferring equipment, molds, dies, systems and processes to contract manufacturers. It will follow a recent successful case study in the medical industry.

Why Should You Attend:

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.

This medical device webinar will provide valuable assistance and give a process and procedures to all regulated companies that are thinking of transferring equipment, molds, dies, systems and processes to contract manufacturers. It will guide you on how to choose the right world class contract manufacturer. It will also cover how important a master validation plan is to meet today’s standards for the FDA and CE Mark.

The presenter will use a case study-approach to guide you in the procedures and process of transferring equipment, systems and 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 Seminar:

• Should a medical company decommission and/or transfer an operation to a world class contract manufacturer.
• Gap analysis.
• Choose a world class manufacturer.
• Cost of validation.
• Risk plan.
• Contract negotiation.
• Master validation plan.
• Mold and component transfer.
• Pitfalls.
• Successful transfer.