THURSDAY, NOVEMBER 3, 2011
Sessions run concurrently from 9 a.m. – 4 p.m. with one-hour lunch break
| Session 303 — Medical Packaging Update |
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Chairs: Kevin Zacharias, Engineering Program Manager, Oliver-Tolas Healthcare Packaging; and Scott Levy, Packaging Engineer, Distribution Dynamics Labs, Inc. (DDL) IoPP — MDPTC (Medical Device Packaging Technical Committee) Update: Dave Olson, VP-Technical Sales, Advanced Web Sterile Barrier Validation From A to Z: Part 1 — Feasibility & Performance Testing: Elon Goldbaum, Principal Manufacturing Engineer, Endologix Sterile Barrier Validation From A to Z: Part 2 — Stability Testing and Process Validation: Elon Goldbaum Round 1 Workshop/Break-Out Sessions A typical sterile medical package project will be outlined and participants will be broken up into groups to discuss potential approaches with respect to the four topics listed below. Each group will be facilitated by an industry expert. Attendees will be given the opportunity to discuss best demonstrated practices with other professionals and to hear how other MDM's approach these issues. a) Test Method Validation: Led by: Todd Dehmer, Sr. Packaging Engineer, American Medical Systems This is a current hot topic in the medical device packaging industry. Test method validation is referenced in ISO 11607 Part 1 and Part 2. This workshop will provide the attendee with guidance on how to approach validation of test methods within their facilities. It will also allow the attendee to benchmark with other MDM’s. b) Package Testing: Led by: Scott Levy The attendee will work collaboratively with other MDM professionals and an industry expert to establish a baseline transportation test plan for a medical device sterile package configuration. Topic will include environmental conditioning, simulated distribution and integrity testing. Regroup for Open Discussion, Lessons Learned, and Ask the Expert
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ABOUT THE CHAIRS
Kevin Zacharias, Engineering Program Manager, Oliver-Tolas Healthcare Packaging
Kevin Zacharias is an Engineering Program Manager at Oliver-Tolas Healthcare Packaging and is responsible for managing the Product Development Department as well as the OnSite package engineering services program. He has worked in medical packaging for over 17 years and his areas of expertise include package design and validation, process validation, simulated distribution testing, in-line printing systems, ISO 11607 and cost savings analysis.
Before joining Oliver-Tolas, Kevin worked as Manager of Packaging Development at Baxter Healthcare and as a Packaging Engineer at Boehringer Mannheim (Roche) Diagnostics.
Kevin holds a BS in Packaging from Michigan State University and an MBA from Butler University. He is a member of IoPP.
Scott Levy, Packaging Engineer, Distribution Dynamics Labs, Inc. (DDL)
Mr. Scott Levy has been the lead packaging sales engineer at DDL for the last twelve years. He is responsible for training and managing five other sales engineers throughout the United States. He takes responsibility to work one on one with clients to ensure their packaging project complies with industry standards and regulations the first time.
He specializes in ISO 11607 and also has an extensive background in shock and vibration testing that crosses all barriers in a vast number of industries.
He is an industry leader in educating medical device manufactures and has spoken on medical device package testing at a number of industry events. He has been published in industry magazines including Pharmaceutical & Medical Packaging News, Healthcare Packaging and Medical Design Technology.
He’s Vice President of the Medical Device Resource Group (MDRG), a coalition of Twin Cities-based companies that together offer the broad expertise needed to successfully develop and market a medical device. Scott is also a member of ASTM and IoPP.
Scott received an Industrial Technology Degree, with a concentration in packaging, from the University of Wisconsin, Stout.
ABOUT THE SPEAKERS
Elon Goldbaum, Principal Manufacturing Engineer, Endologix
Elon graduated from Michigan State University in 1999 with a BS in Package Engineering. He has over 11 years experience in the medical packaging field including consumable reagent packaging for Beckman Coulter and medication delivery packaging for Baxter Healthcare. He was employed at Edwards Lifesciences in Irvine California for 5-1/2 years, managing the Transcatheter Heart Valve cardiovascular medical device packaging product line. He recently has taken a position as a Principal Manufacturing Engineer working at Endologix in Irvine California.
Todd Dehmer, Sr. Packaging Engineer, American Medical Systems
Todd Dehmer is a Sr. Packaging Engineer for American Medical Systems. Prior to accepting the position with American Medical Systems Todd was a Sr. Packaging Engineer for St. Jude Medical's Atrial Fibrillation Division. Prior to St. Jude Medical, Todd was a Packaging Engineer for International Multifoods and also a Packaging Engineer/Project Manager for DDL, Inc.
Todd graduated from the University of Wisconsin Stout with a BS in Industrial Technology and a concentration in Packaging. He is a Certified Packaging Professional (CPP) by the IoPP (Institute of Packaging Professionals). He is currently a member of the ASTM D10 Packaging Committee and the F02 Flexible Barriers Committee.
Dave Olson, VP-Technical Sales, Advanced Web
Dave Olson has been involved with labeling terminally sterilized device packages for over 30 years. Dave has presented and written nationally on labeling issues in the medical device industry and is the long time chair of IOPP’s MDPTC Labeling Task Group He also authors the popular blog, “Ask Dr. O”, where labeling issues are explored with more than a touch of humor.