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

By:
Rob Braido,
Principle at Visionary Consulting LLC
Michael Mims,
Plant Manager at GW Plastics
Coming soon.. Please contact customer care for new schedule

Course Description:

Course "Transferring a Medical OEM Molding and Assembly Operation to a Manufacturer With 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.

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.

This interactive workshop will guide you in the procedures and process of transferring equipment, tools or processes to meet the standards for the new 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 validations properly. All new products have to be designed and transferred to operations or a supplier in the same way. Validations need to meet all the new standards. This training will provide a step by step process to guide you in your transfer.


Areas Covered:

Who will Benefit

  • 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 Choose the right “World Class” quality supplier.
  • The transfer plan.
    • The equipment transfer.
    • The tool transfer.
    • The assembly transfer.
  • Multi-functional team approach/responsibility.
  • Operations, quality and validations.
  • Pitfalls and downsides.
  • Conduct a “Lessons Learned Program”.

This seminar will provide valuable assistance and give a process and procedures to regulated companies that need to transfer equipment, molds, dies, systems and processes in-house or to suppliers with proper quality standards, procedures, verification and validations.

  • OEM plant managers and operation personnel in the medical industry
  • Manufacturing engineers
  • R&D, product development engineers and managers associated with validation of new products
  • QA, Regulatory Affairs and validation teams
  • Validation specialists
  • Senior management
  • Suppliers entering into the medical industry
  • Suppliers to the medical industry
  • Consultants
  • Corporate auditors



Course Outline:

1.Gap Analysis on whether to invest in the molding division or move it to a World Class Molder/Assembler

  1. Logically assess your current situation
    1. Corporate needs
    2. Strategically
    3. Tactically
    4. Financially
    5. Resources
    6. Equipment
    7. Product
  2. Cost of keeping up with quality and process technology
  3. Cost of upgrading process technology and quality performance
  4. What is the company’s core competences and focus (Quality – Service – Cost)
  5. Understanding present and future risk to product, patient, clinician and OEM

2. Choosing a World Class Manufacturer

  1. Investigate World Class Suppliers in your medical industry segment your product niche
  2. Benchmark
  3. Due diligence
  4. Developing a rapport
  5. Understanding the needs and requirements of the OEM and the international medical industry - validation and quality engineering
    1. Industry standards
    2. International standards
    3. Validation
    4. 6 Sigma
    5. Green Belts
    6. Black Belts
    7. ISO 9001 – Quality Management and continuous improvement
    8. ISO 13485 – Quality Management for design and manufacture of medical devices
    9. ISO 14971 – Risk Assessment
  6. Improved efficiencies and costs
    1. Cost to manufacturer VS purchased goods
    2. Soft costs/Hidden costs
  7. Validation resources
    1. Cost of validation

3. Setting up a contract

  1. Validation and quality standards expected
  2. Safety stock/Inventory build plan
  3. Standard costs VS contract costs
  4. Timing of transfer and qualification
  5. Liability
  6. Risk analysis

4. Develop a Master Validation Plan

  1. Develop an IQ, OQ, PQ for each mold
  2. Develop and IQ, OQ, PQ and PPQ for each assembled product code
  3. Develop IQ, OQ, PQ for packaging
  4. Develop a sterilization validation plan
  5. Develop a total process validation plan

5. Tool Transfer

  1. Tool and process improvement
    1. Upgrade equipment process and tools
  2. Use of automation
  3. New tools
  4. Lower costs

6. Assembly transfer

  1. Assembly and process improvement
    1. Upgrade of process equipment
  2. Use of automation

7. Celebrate

  1. Celebrate those that highly contributed with the successful transfer
  2. Ongoing development

8. Pitfalls/downsides

  1. Quality and validation
  2. Notifying bodies (FDA, CE, Japan, Canada)
  3. Expectation change internally VS externally
  4. Internal supplier to external supplier
  5. Accounting shock
    1. Internal costs VS external costs
    2. Accounting standards
    3. Soft costs
  6. Culture shock
  7. Tool condition
    1. Hand tools
    2. Bridge tools
    3. Full production tools
    4. End of arm automation
  8. Tool performance
  9. Process equipment condition
    1. i. Manual processes
  10. Process equipment performance
  11. Raw material transfer
    1. Resin transfer
    2. Components
    3. Tubing
    4. Packaging, labels and inserts
    5. Specs
  12. Incoming inspection
  13. Change in inventory planning
  14. Quality expectations
  15. Validation sequencing
  16. Sterilization
  17. New product development / Prototyping

9. Conduct a “Lessons Learned Meeting/s”

  1. Mistake proofing the assembly
  2. Mistake proofing the testing regiment

10. Conclusion




Meet Your Instructors

Mr.Rob Braido
Principle at Visionary Consulting LLC

Mr.Rob 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.Michael Mims
Plant Manager at GW Plastics

Mr.Michael Mims has 15 years of experience in medical manufacturing and is a six sigma black belt. Currently, Michael works for GW Plastics (Plastic News Processor of the Year 2010) as Plant Manager overseeing the contract manufacturing facility in Tucson, AZ. His facility was recognized as the plant showcase in Modern Plastics' 2011 MD&M issue.

Mr. Mims is an expert at production transfer and startup because his experience also involves ongoing life cycle support and improvements. While at Abbott Nutrition, Michael was recognized as “Engineer of the Year” for his efforts in product and process improvements.




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Testimonials

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



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