Transfer OEM Medical Device Molding Or Assembly Production to A Contract Manufacturer - Decision Making Process With Procedures and Full Validation

Robert L Braido

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This webinar will provide methodology, processes and procedures to all medical OEM’s that have to make critical decisions concerning transferring equipment, molds, dies, systems and processes to contract manufacturers. It will follow a recent successful case study in the medical industry.
Course Objective:
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. With the economy, many medical OEMs are deciding whether to invest in upgrading equipment, technology, new personnel, transfer it to a lower cost in-house facility or transfer it to a contract manufacturer. In many cases this could save the OEM from investing in costly bricks and mortar, new technology and higher labor cost. It also frees up floor space for new product initiatives. 
This medical device webinar will provide valuable assistance and give methodology, processes 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 a standard.
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.
This webinar on outsourcing medical device manufacturing will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house. If you decide to transfer production, then this training will detail the options and next steps to transferring it to the right facility or contract manufacturer.
This session will also benefit contract manufacturers, since they have to be ready for a seamless transfer of production by understanding their responsibility and the requirements for a medical device transfer, including the transfer process, validations and the pitfalls that could lead to delays.
Course Outline:
  • Senior management responsibility
  • Team responsibility
  • Due-diligence
  • Gap Analysis
  • Decision Making
  • Project Management
  • Choosing A Contract Manufacturer
  • Request for Information (RFI), Request for Proposal (RFP), Request for Quote (RFQ)
  • Supplier Audits
  • Final Selection & Contract Negotiation
  • Cost of validation.
  • Risk plan.
  • Contract negotiation.
  • Master validation plan.
  • Mold and component transfer.
  • Pitfalls.
  • Supply Chain
  • Master Validation Plan
  • Transfer Process
  • Benefits
  • Pitfalls
  • Post Review
  • Celebrate
Target Audience:
This webinar will provide valuable assistance and give a procedure to the medical device companies that are in the decision making process of transferring production to a contract Manufacturer or transferring it to another facility. 
The personnel who will benefit include:
  • At Medical Device OEM's:
  • Senior Decision Makers
  • R&D and Product Development Engineers and Managers
  • Pilot Plant Manager
  • Plant and Production Managers
  • Project and Process Engineers
  • Supply Chain Managers
  • Global Contract Manufacturing Transfer Teams
  • Global Strategic Managers
  • Quality and Validation Teams
  • Quality and Corporate Auditors
  • At Contract Manufacturers:
  • Senior Decision Makers
  • Senior Strategist looking to get into medical device contracting
  • Contract Manufacturers working in the medical industry
  • Plant and Production Managers
  • Engineering and Contract Manufacturing Transfer Teams
  • Project and Process Engineers
  • Quality and Validation Teams
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Robert L Braido, Principle at Visionary Consulting LLC.

Mr. Robert Braido, has 35 years of experience in the medical industry. He is presently the principle at Visionary Consulting LLC and has been consulting with medical OEM's and suppliers to the medical industry for over 5 years.

Mr. Braido's has a broad breath of industry experience in prototype/product development, global strategic/tactical planning, technical due diligence/gap analysis, engineering and strong leadership skills to help develop new products and businesses. He has had great success working at Ethicon Endo-Surgery a J&J Company, Teleflex Medical, The Tech Group and Baxter Healthcare with increasing responsibilities to the level of VP of Advanced Technologies. He was a member of the Board of Directors for the SPE Medical Division for over 10 years and elected Chairman of the Medical Division.

Mr. Braido was selected as a member of a Johnson & Johnson Integration Team that took a small fledgling company with totally new products, technologies and structure from $75 million to $850 million in 5 years. His career is built on the ability to motivate, lead and coach people in different disciplines throughout the medical industry. The key factor has been driving creativity and innovation.

While working for J&J he was elected, as the Consortium Chairman for the Government Reinvestment Program along with MIT, the National Science Foundation and seven leading Fortune 200 companies to commercialize emerging technologies.

He has published numerous technical and leadership papers and articles. In the past thirty years he has been invited to share his experiences at a number of technical conferences and symposiums on presentations relating to the medical industry on prototype/product development, due diligence/gap analysis, project management, innovation and creativity.

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