Description:
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
- Consultants
- Corporate auditors
Course Outline:
Day One – Mold Transfer OEM to World Class Contract Manufacturer |
Day Two – Mold or Product Transfer OEM to World Class Contract Manufacturer |
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Meet Your Instructor
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Rob 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. |
Register Now
Online using Credit card
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Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
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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