Course Description:
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 |
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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.
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Course Outline:
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1.Gap Analysis on whether to invest in the molding division or move it to a World Class Molder/Assembler
2. Choosing a World Class Manufacturer
3. Setting up a contract
4. Develop a Master Validation Plan
5. Tool Transfer
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6. Assembly transfer
7. Celebrate
8. Pitfalls/downsides
9. Conduct a “Lessons Learned Meeting/s”
10. Conclusion |
Meet Your Instructors
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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. |
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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. |
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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Local Attractions
Windy
One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.
Adler Planetarium and Astronomy Museum
The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!
Arlington International Racecourse
With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.
Art Institute of Chicago
You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.
Auditorium Building and Theatre
A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.
Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.
