Transferring A Medical OEM Molding or Assembly Operation to A World Class Contract Manufacturer With FULL Validated Systems And Processes
Rob Braido, Principle at Visionary Consulting LLC.
Coming soon.. Please contact customer care for new schedule
||Course "Transferring A Medical OEM Molding or Assembly Operation to A World Class Contract Manufacturer With FULL Validated Systems And Processes" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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
- 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”
Who will Benefit:
This interactive seminar will provide valuable assistance and give a process and procedures to regulated companies that need to transfer whole operation, product, equipment, molds, dies, systems and processes in-house or to suppliers with proper quality standards, procedures, verification and validations. It will follow a recent successful case study in the medical industry.
- Senior management
- Strategic management
- OEM plant managers and operation personnel in the medical industry
- Manufacturing engineers
- R&D, product development engineers and managers
- QA, Regulatory Affairs
- Validation engineers
- Supply chain management
- Contract manufacturers to the medical industry
- Contract manufacturers entering into the medical industry
- Corporate auditors
Day One – Mold Transfer OEM to World Class Contract Manufacturer
Day Two – Mold or Product Transfer OEM to World Class Contract Manufacturer
1. Gap Analysis on whether to invest in the molding division or move it to a World Class Molder/Assembler
- Logically assess your current and future corporate needs
- Corporate needs
- Cost of keeping up with quality and process technology
- Cost of upgrading process technology and quality performance
- What is the company’s core competences and focus
- Understanding present and future risk to product, patient, clinician and OEM
2. Choosing a World Class Manufacturer
- Investigate World Class Suppliers in your medical industry segment your product niche
- RFI, RFP, RFQ
- Due diligence
- Understanding the needs and requirements of the OEM and the international medical industry – validation and quality engineering - Both
- Industry standards
- International standards
- ISO 13485 – Quality Management for design and manufacture of medical devices
- ISO 14971 – Risk Assessment
- Improved efficiencies and costs
- Cost to manufacturer VS purchased goods
- Soft costs/Hidden costs
- Validation resources
- Supplier audits
- Supplier selection
- Break up in teams
- Develop an action plan for a future transfer someone has brought with them
- Use all the information discussed in Day 1 and apply it to a molding or product transfer
- Use a “Gap Analysis” case study to develop action plan to take back
- Each team to present a plan
- Depending presentation length they will be finished the next morning
5. Final selection
- Setting up a contract
- Contract negotiation
- Validation and quality standards expected
- Safety stock/Inventory build plan
- Timing of transfer and qualification
6. Develop a Master Validation Plan
7. Validation Protocols
8. Project Management
9. Supply Chain Management
10. Equipment, Tool and process transfer
- Tool and process improvement
- Use of automation
- New tools and equipment
- Lower costs
- Tool condition
- Tool performance
- Process equipment condition
- Process equipment performance
- Raw material transfer
- Incoming inspection
- Ongoing development
14. Pit falls/downsides
- Quality and validation
- Notifying bodies (FDA, CE, Japan, Canada)
- Accounting shock
- Internal costs VS external costs
- Culture shock
- Tools and equipment
- Change in inventory planning
- Quality expectations
- Validation sequencing
- New product development / Prototyping
- Celebrate those that highly contributed with the successful transfer
16. Post review
- Conduct a “Lessons Learned Meeting(s)”
Meet Your Instructor
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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What past attendees say:
Lesson learned on OEM and what would make things easier was good about this event. Lesson learned on Transfer from case study and check lists will come very handy. ComplianceOnline.com's Customer care services were extremely helpful. Thanks
- Operations Program Manager, Abbott
"Validation Mater Plan" was most valuable topic for me, exactly what I am doing with. The design of the presentation was appropriate and support materials are very useful.
- VP Operations, Roche Medingo
Length of the seminar was most appropriate. I like the knowledge delivered on topic "Process/Pitfalls Discussion". My colleague referred me to this seminar and certainly I will help my friends by referring ComplianceOnline seminars to them.
- Director of Procurement, Siemens Healthcare Diagnostics
It was good learning throughout the program. There is always something to gain from other's experience. "Validation Plan - Sec. 6, 7, 8" was most valuable for me as they are directly involved with my job function.
- Project Engineer, EVCO Plastics
I would like to Thanks to ComplianceOnline for coordinating this seminar and selecting good speaker. Speaker was connected to subject with good example selection and material. "Transfer case study and Validation Requirement Protocols" was most valuable topic as I am involved in it.
- Business Unit Manager, JAMAK
Seminar was well organized and coordinated. The subject was well chosen and Presenter was knowledgeable. Thanks!
- Facilities and Engineering Manager, American Micro
Course "Transferring A Medical OEM Molding or Assembly Operation to A World Class Contract Manufacturer With FULL Validated Systems And Processes" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Regulatory Affairs Certificate Program (By Regulatory Affairs Professionals Society RAPS)
The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals.
Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.
How to get RAPS certificate?
After completion of course "Transferring A Medical OEM Molding or Assembly Operation to A World Class Contract Manufacturer With FULL Validated Systems And Processes" RAPS certificate will be issued to attendee.
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