ConferenceMonday, June 2, 2008
Randall Troutman, CPP, Technical Director, Medical Engineering Department, Oliver Medical Abstract Information to come About the Instructor Randall Troutman, CPP, Technical Director, Medical Engineering Department, Oliver Medical Randall Troutman, Certified Packaging Professional 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 Karen Greene, CPP, Technical Director, DDL West 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 Karen Greene, CPP, Technical Director, DDL West 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. Her medical device and pharmaceutical packaging experience has included leadership positions with IMED Corporation(now Cardinal Health), Ohmeda Medical, Edwards Lifesciences and Allergan. She has led teams of individuals responsible for medical device and pharmaceutical package development, validation and production implementation and solved many tough problems related to sterile barrier package integrity, package design, test method development and quality related issues. Ms. Greene has worked extensively with off-shore manufacturing operations, facilitating packaging operations transfers and the establishment of packaging lines. She has also led teams responsible for documentation, configuration management and label development and control. Ms. Greene is currently the Technical Director for DDL West, a package and product testing services provider. She is the Vice President of the southern California Chapter of the Institute of Packaging Professionals, a certified packaging professional(CPP) and an active member of the IoPP Medical Device Task Force Group. Ms. Greene is a member of the ASTM F02, Flexible Barrier Packaging committee. She is a graduate of Holy Cross College, Worcester, MA and holds a professional certificate in engineering management from the Univ. of California, San Diego. Medical Packaging Conditioning: Aging and Distribution Simulation Curtis Larsen, Principal, Spartan Design Group, LLC 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 Larsen, Principal, Spartan Design Group, LLC 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.
Root Cause Package Failure Analysis Lora Keena, Director of Quality / Regulatory, Oliver Medical 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, Director of Quality / Regulatory, Oliver Medical 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. Lora was previously president of Regulatory Consulting Services; director of QA/RA at Inrad, Inc.; and director of QA/RA at LMI Medical. Sterilization and Packaging Materials Karl Hemmerich, Plant Manager / Gamma Irradiation Facility, Steris Isomedix Services 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 Hemmerich, Plant Manager / Gamma Irradiation Facility, Steris Isomedix Services 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). Abrasion Testing of Packaging Films Mary Czarnopys, Converted Products Marketing Manager, Perfecseal Abstract Information to come About the Instructor Mary Czarnopys, Converted Products Marketing Manager, Perfecseal Mary Czarnopys began her professional career as a Chemist at the American National Can's (ANC) Neenah Technical Center. Shortly after she took on the role of Quality Assurance Supervisor at ANC's Menasha Plant and later became the Quality Assurance Manager for Pharma Center Shelbyville. A year later Mary Czarnopys took on the role of Plant Manager. In 2000, Mary became the Coating Business Unit Manager at Avery Dennison in Greenfield, IN. She took a year off from her profession and in 2002 Mary took on her current role of Converted Products Marketing Manager for Perfecseal Inc, a division of Bemis Corporation. What to Expect from an EC Notified Body When Being Audited for Compliance to EN/ISO 11607-1: 2006 & -2 Mike Scholla, Senior Consultant, DuPont Nonwovens Abstract Information to come About the Instructor Mike Scholla, Senior Consultant, DuPont Nonwovens Dr. Michael H. Scholla is a Senior Consultant within DuPont Nonwovens located in Wilmington, Delaware. He serves as a member of the medical packaging and medical fabrics businesses. Mike has a diverse research background with over forty publications and six patents. He is actively involved in numerous industry groups including: Treasurer and member of the Executive Committee of the Association for the Advancement of Medical Instrumentation (AAMI) and a member of the Sterilization Standards Board and Committee on Standards Strategy. Mike is also the Convener of ISO TC198 WG7 on Medical Packaging responsible for the harmonized standard ISO/EN 11607. He also chairs the Healthcare Committee for INDA and is a member of the US Postal Service Technology Board.
The Art and Science of Thermoforming Jason Crosby, Medical Business Manager, Plastic Ingenuity 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, Medical Business Manager, Plastic Ingenuity 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. Additionally, Mr. Crosby has presented nationally on various topics related to medical packaging and thermoforming.
|
||
