| Conference
Monday, January 28, 2008 - 9 a.m. to 4 p.m.
Abstract Information to come. About the Instructor Randall Troutman holds a B.S. from University of Wisconsin-Stout in Packaging and a MBA from Christian Brothers University in Memphis, TN. He has worked for Kimberly Clark, Medtronic, and Smith & Nephew. He is currently employed at Oliver Medical working in the Medical Engineering Department specializing in medical packaging material technologies. He is a member of the Institute of Packaging Professionals Medical Device Packaging Committee as well as the Association for the Advancement Medical Instrumentation packaging working group.
“The Compliance Sweet Spot” Employing the TIR 22 for Effective ISO 11607, part 1 and part 2 Compliance Abstract This presentation will highlight key activities that provide the necessary competitive advantage for sterile medical device packagers as they engage in the competitive race to market. Geared towards those relatively unfamiliar with the details of compliance to ISO 11607, or how best to follow its “how to” guide the TIR 22, this presentation will serve as an introduction to both, and frame them within a “12 Steps to Market” for easy compliance.
About the Instructor Ms. Greene is a tenured package engineering professional with 18 years of experience in the medical device and pharmaceutical packaging industries. The first 7 years of her 25 year career were in the food packaging industry where she held professional positions with Nabisco Brands and Thomas J. Lipton Company.
Medical Packaging Conditioning: Aging and Distribution Simulation Abstract When packaging engineers do sterile barrier system aging studies or package system design performance evaluation there is often confusion around what is being tested, what passes, what fails and how all the different analytical tools used for sample evaluation fit into the successful outcome of their work. My presentation will help sort out what the tests are and what they are not, how the sample preparation and stressing fits into the process and what is important in the final outcome and report. About the Instructor Curtis L. Larsen (Curt) is Package engineering consultant for DuPont Medical Packaging and Spartan Design Group. Mr. Larsen has over 35 years experience in sterile medical device packaging. He is active at all levels of American Society of Testing and Materials (ASTM International) Committees F02 Flexible Packaging Committee, D10, Packaging and F04, Medical and Surgical Materials and Devices. Mr. Larsen is a member of the Association for the Advancement of Medical Instrumentation (AAMI) administered US sub-TAG for ISO/TC198/WG7 - Medical Packaging and has been involved with all aspects of the development, publication and revisions to the ISO 11607 standards. He is a Certified Packaging Professional (CPP) by the Institute of Packaging Professionals (IoPP), is a member and co-chair of the Medical Device Packaging Technical Committee. He was inducted into the IoPP College of Fellows and voted The 2006 IoPP Member of the Year. Mr. Larsen was awarded a B.S. degree in Packaging Technology from Michigan State University in 1967, is a member of the Packaging Alumni Association and a member of the M.S.U. School of Packaging Industrial Advisory Board as well as a member of the University of Wisconsin - Stout Packaging Department Industrial Advisory Committee. Mr. Larsen is a member of the editorial advisory board of the Canon Communications publication Pharmaceutical and Medical Packaging News. In June 2004 Mr. Larsen was selected by Canon Communications Medical Device & Diagnostics Industry magazine as one of the 100 Notable People in the Medical Device Industry.
Test Method Specifics (Peel vs. Burst) Abstract Information to come. About the Instructor Mark A. Escobedo is the Chief Technologist at Westpak, Inc. With a degree in Package Engineering from San Jose State University, Mark brings ten years of packaging experience to his field and has overseen the testing and design evaluation of thousands of products and packages. In addition to writing articles for industry publications, Mark also conducts seminars on a variety of testing related topics. He is a member of ISTA, ASTM, and IoPP.
Sterilization and Packaging Materials (effects / considerations) Abstract This presentation will review common industrial sterilization techniques (radiation, ethylene oxide, moist, dry heat, vapor-phase hydrogen peroxide, and Ozone) and their possible effects and/or limitations for medical product designs utilizing common medical polymers. AAMI's new TIR #17 " Compatibility of Materials Subject to Sterilization" will be reviewed as to its content so that the attendee can better understand this valuable new resource. About the Instructor Karl James Hemmerich is Plant Manager of the Sandy, Utah Gamma Irradiation Facility and Customer Technical Support and Market Education Specialist for STERIS Isomedix Services. Prior to joining STERIS, Karl was President of Ageless Processing Technologies, an engineering consulting network specializing in sterilization selection and program development and process validation. Before founding APT, Karl spent seven years with Ivac Corporation, six years with Cutter Laboratories, and eight years with Becton Dickinson. Karl was recently selected as one of the 100 Most Notable People in the medical device industry (by MD&DI). He is a member of the editorial advisory board for Medical Device and Diagnostic Industry magazine and is a member of the AAMI SWG96 developing Technical Information Report # 17 covering materials selection, qualification / validation test techniques (i.e. accelerated aging), and quality processing methods. He has written and presented papers on Radiation Sterilization and Materials Selection for many corporations, universities, and professional organizations (including: MDDI, SPE, FDA, HIMA, & ASQC).
Root Cause Package Failure Analysis Abstract A brief discussion on general problem solving methods for determining Root Cause Package Failures followed by three (3) case studies surrounding common, yet critical, package failures. About the Instructor Lora Keena is Oliver Medical's director of QA/RA and is responsible for FDA and ISO registration, inspection, and compliance for US and European facilities. Lora's areas of expertise include international auditing; quality systems; and suppliers, product, and process validation. She has extensive experience and proficiency in FDA cGMP, QSR, MDD, FDA and ISO 13485 registration and inspections, 510(k) pre-market notification, international medical device registrations, supplier management and related regulatory affairs.
The Art and Science of Thermoforming Abstract This thermoforming case study follows a medical packaging project through its development cycle. The unique perspective of this presentation will be the analysis of how art and science interact during product development and thermoforming, ultimately resulting in a flawlessly executed thermoformed product. Complicating all projects are the constraints assigned by the MDM, typically these constraints can create road blocks for execution. This case study will explore these constraints and ultimately the impact on the outcome of the project. About the Instructor Jason Crosby is the Medical Business Manager for Plastic Ingenuity, Inc., located in Cross Plains, Wisconsin. Plastic Ingenuity, a custom thermoforming manufacturer, has formed its reputation in the industry by providing innovative packaging solutions, being customer focused and flexible. Mr. Crosby is responsible for all facets of Plastic Ingenuity's medical packaging business; dealing daily with operations, business development, package engineering and validation issues. He has a bachelor's degree from the University of Wisconsin-Whitewater and an MBA from the University of Wisconsin. He has 10 years of thermoforming industry experience with Plastic Ingenuity. He is a member of the Society of Plastic Engineers and Institute of Packaging Professionals.
Successful Projects with a Package Engineering Consultant Abstract
About the Instructor Jan Gates is a Principal Packaging Engineer for Abbott Vascular, formerly Guidant. She has over 30 years package engineering experience in food, pharmaceutical, detergent and medical device industries. She has focused on optimizing companies' packaging systems by starting at the user end and working back for new or existing products. Her work has included cold chain shipping, several types of sterilization methods, production line efficiency increases, packaging system validations, as well as documentation procedures and policies with multiple types of packaging materials and production lines. For the last 15 years she has worked in the medical device industry for EU/FDA/Japanese and other countries requirements. She is, also, an active member on the ASTM D10 and F2 (rigid and flexible packaging) groups developing industry standard test methods and guides, the AAMI TIR 22 revision group and the IoPP Southern California chapter revitalization group.
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