Presenter:  Jan Gates

Location: Temecula City Library

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Start Date: Feb. 16th, 2012
Start Time: 6:00 pm
Price: $ 20.00 – 25.00


Title:  Package Integrity and Best Practices in Medical Device Packaging Validation

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Package Integrity and Best Practices in Medical Device Packaging Validation

Abstract:

When I worked with IBM as a Principal in IBM Global Services, we presented an “impossible to turn down” proposal to a customer to convert every one of their legacy systems to SAP. The financial proposal was extremely attractive! We proposed to execute all conversions virtually for free. Top executive management was extremely impressed and the fact that it was a proposal from IBM to use exclusively IBM services we thought would seal the deal.  However, we lost the opportunity to complete the project! Come and hear why!
This presentation will address what was called Applications Portfolio Management (APM) and the vital need for converting legacy systems to new, more effective systems. This was in a climate immediately after mergers and acquisitions had flooded the Corporate and IT landscape with numerous platforms and diverse systems. It will also address the Project Management challenges involved in such a large undertaking.  Outsourcing and Offshoring were also vital part of the economic picture and will also be discussed.
So, you may ask: How was it possible that a company could turn down this unbelievably attractive  offer?  Come attend this informative and entertaining presentation and find out!

It has been said some manufacturers “over package” their medical devices.  Medical device packaging is essential to ensuring the safety and efficacy of a medical device as delivered to the end user.  This cannot be overstated for devices with a “sterile” label claim.  This presentation focuses on the upstream decisions made by package designers and discusses how they can best assess and meet the device requirements  and its end user interface, while simultaneously achieving full compliance with international packaging regulatory requirements for sterile medical devices.

Speaker Bio:


Jan Gates is the owner and founder of PackWise Consulting (PackWiseConsulting.com). She has more than 30 years of experience in package engineering with foods, pharmaceuticals, detergent, and medical devices, most recently with Abbott Vascular. Her work includes individual contributions and leading teams for packaging material and systems design/development to meet regulatory, product protection, and customer use requirements with production optimization, validation, and minimal packaging.  Jan was a task group leader for the AAMI TIR 22 document — a U.S. guidance document on compliance with the ISO/EN 11607-1 & -2, Terminally Sterilized Medical Device Packaging.  She is a member of the ASTM D10 and F2 (rigid and flexible packaging) groups developing industry standard test methods and guidance, and the IoPP Southern California chapter revitalization group.