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Risks/Rewards of Sourcing China for Medical Device - Webinar

solutionSourcing in China is an increasingly popular strategry for medical device, however, business ethics can be very different in Asian companies as opposed to North American or European companies. It is almost a certainty that you can be assured of the lowest initial price with this strategy, but organizationally are you aware of the overall business risk you are assuming?

One tragic example involves the blood thinning drug Heparin. Baxter is a provider of this formulation. According to the TV program "60 Minutes", Baxter sourced a key active component through a third party who in turn sourced the component in China. The Chinese supplier provided a component that was structurally close to the active component of Heparin but did not have the redeeming properties of the real component. During quality testing, neither the third part nor Baxter was able to pick up on this difference. This scenario has led to a number of deaths and litigation involving Baxter, the FDA, and individuals. The final impact has yet to be determined, but the final financial impact alone will likely be in the billions of dollars. Of course, the legal teams are not going after the Chinese supplier or even the third-party...just Baxter.

Below are some common issues for US and European companies dealing with Chinese suppliers:

  • Unapproved material substitutions
  • Unapproved process changes
  • Unapproved design changes
  • Totally out of control processes
  • Operator certification
  • Sourcing by second-tier suppliers (the factory you audited may not be the factory where your product is produced)

Yet with all of the above, it is possible to find low-cost, consistent, high-quality suppliers in China. Take this webinar and learn how to reduce the risk of sourcing in Asia.

Cost: $29.99

Length: 1 Hour

Click on the "Add to Cart" button or call 1-719-282-1143 to register for this webinar.

Webinar Dates
 

Click on the tabs below for more information.

Agenda

  • Brief introductions
  • Amazing medical devices
  • Some unfortunate tragedies in medical device
  • Why you cannot treat Asian suppliers using the same approaches as with North American suppliers.
  • Cultural differences of which to be aware.
  • How to find candidate suppliers who can meet your needs.
  • Do/Don't regarding supplier assessments
  • Finding partners who can help with the selection process
  • How to link with effective local auditors
  • Contracts have different meanings in China than in North America
  • Guidelines on development of contracts
  • On-going audits
  • How to ensure goods are as specified when shipment arrives in USA
  • Wrap-up with questions and answers

 

Trainer

Robert Launsby has taught hundreds of students Process Validation techniques. Bob has consulted with numerous companies in the area of FDA protocols for Process Validation. He is co-author of "Process Validation for Business Success", "Design for Six Sigma", "Engineering Today's Designed Experiments", "Understanding Industrial Designed Experiments" and "Experimental Design for Injection Molding". Bob's presentations are lively and informative. His examples are practical and thought provoking.

Dates

The dates and locations are listed below:

Date Start Time
September 30, 2011 9:00 am MST
November 9, 2011 2:00 pm MST
January 20, 2012 9:00 am MST

Cost

Cost: Only $29.95

Guarantee

Launsby Consulting webinars and products are fully guaranteed. If any of our webinars do not meet your needs, contact us and we will promptly send you a refund. If any of our products fail to meet the highest standards of quality and performance, please return them in like-new condition in their original packing materials, and we will send you a refund.

 

Who Should Attend?

Professionals directly involved in the development and manufacturing of medical devices and meeting the FDA's quality system requirements. Individuals associated with vendor selections, regulatory affairs, quality assurance, process development or manufacturing will find this informative webinar extremely valuable.

 

Register Early - class sizes are limited for optimal interaction and instruction.

Call 1-719-282-1143 to Register.

If you have any questions, please feel free to email us at or call us at 1-719-282-1143.

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