AGENDA                           PRESENTERS

Keynote Speaker

Ed Dunn, Head, Global Supply Chain Packaging Center of Excellence
Johnson & Johnson

Ed Dunn is Head of the Global Supply Chain Packaging Center of Excellence at Johnson & Johnson. He leads a newly created group at Johnson & Johnson that is responsible for leveraging the combined packaging capabilities in the J&J Enterprise to provide rapid solutions to packaging-related issues, define standards and processes to increase efficiency, improve quality, decrease supply chain interruption and introduce innovation into the J&J business units. A pharmacist by early training, Dunn’s career has evolved into managing packaging technologies for companies including GSK, Merck and Johnson & Johnson-DePuy Synthes. Dunn has a bachelor’s degree in Pharmacy from the University of the Sciences in Philadelphia and an MBA from the University of Pittsburgh Katz Graduate School of Business.

Presentation: Industry 4.0: Considerations for Packaging

Dan Burgess, Packaging Engineering Fellow, Exploratory Packaging Group
Boston Scientific

Dan Burgess is a Packaging Engineering Fellow at Boston Scientific in Maple Grove, MN. Dan earned a BS in Packaging Engineering at UW-Stout and an MS in Technology Management at the University of St. Thomas. He has 10+ years of medical device industry experience, with a focus on technology and test methods. Prior to entering the medical device industry, Dan worked as an injection mold maker and machinist for eight years. 

Presentation: Smart Packaging—Technology that Adds Value

David DiVaccaro, Principal
DiVaccaro Consulting Group

David DiVaccaro is Principal at the DiVaccaro Consulting Group, LLC, with an extensive background in package design, operations and supplier interactions. He is experienced in leading and performing packaging risk assessments and audits. David is Six Sigma Process Excellence Black Belt Certified, and his specialties include medical and pharmaceutical package design, along with design and process validation. His background includes many years as a Packaging Engineer and Principal Packaging Engineer at DePuy Synthes.

Presentation: Six Steps to Successful Remediation

Dhuanne Dodrill, President
Rollprint Packaging Products

Dhuanne Dodrill is the President of Rollprint Packaging Products, a flexible packaging converter specializing in technically innovative products for the healthcare, food and industrial markets. With more than 30 years of experience in the flexible packaging industry, Dhuanne has worked in a variety of technical, quality assurance and management positions. She is the chair of ASTM’s Committee F02 on Primary Barrier Packaging, serves on the Board of Directors of the Flexible Packaging Association, is on the Executive Committee of the Sterilization Packaging Manufacturers Council, is active with IoPP’s Medical Packaging Technical Committee and serves on the Executive Committee of the Board of Directors of Summit Insurance. Dhuanne has a B.S. in Chemical Engineering (with honors) from the University of Illinois Urbana-Champaign.

Presentation: Material Selection in Flexible Packaging

Nick Layman, Staff Franchise Packaging Development Engineer

Nicholas Layman is Staff Franchise Package Development Engineer at Johnson & Johnson–Ethicon. He has 15 years of experience as a packaging engineer, with eight years in medical device packaging. He currently leads a team developing customer-focused and quality-compliant sterile medical device postponement solutions for regional markets globally. In the past, he led the franchise through the Tyvek® transition and launched many new devices in custom sterile barrier packaging. He has received an Earthwards award for implementing sustainable features into product packaging. Nick also has extensive experience in structural and protective packaging design and testing, having developed custom foam cushioning systems and returnable packaging solutions. 

Scott Levy, Packaging Engineer

With more than 20 years of medical device testing experience, Scott Levy specializes in helping medical device manufacturers comply with ISO 11607 and other industry standards. He has an extensive background in shock and vibration testing that crosses all barriers in a vast number of industries. Scott is the lead packaging engineer at DDL Inc., where he is responsible for training and managing two other sales engineers throughout the United States. He takes responsibility for ensuring complete satisfaction with every project and is an advocate for making sure DDL’s clients packaging systems are in compliance with industry standards and for FDA and ISO (CE Mark) registration. Scott is a big advocate of getting things done right the first time to save his clients money, but more importantly, making sure they meet their medical device launch date on time.

Scott is an industry leader in educating medical device manufacturers and has spoken on medical device package testing at a number of industry events (MDM, HealthPack). He has been published in industry magazines including Pharmaceutical & Medical Packaging News, Healthcare Packaging and Medical Design Technology. Scott earned an Industrial Technology Degree, with a concentration in packaging, from the University of Wisconsin-Stout.

Panel: Systemic Approach to Seal Strength

Thomas McNabb, Principal Project Engineer
Medtronic Neurovascular

Thomas McNabb holds a Master’s degree in Packaging Science from Rochester Institute of Technology in addition to a Bachelor’s degree in Economics from California State University at Los Angeles. He has been in the packaging industry for more than 25 years, including positions at UPS, Black & Decker, Johnson and Johnson, B Braun and Edwards Lifesciences. Thomas is a member of the Institute of Packaging Professionals and is a member on the ASTM International F02 and D10 committees. He has developed expertise in package testing, thermoforming, medical device packaging, package prototyping and value improvement. Thomas is currently Principal Project Engineer at Medtronic Neurovascular.

Panel: Systemic Approach to Seal Strength

Rod Patch, Senior Director, Packaging Center of Excellence
Johnson & Johnson

Rod Patch is Senior Director, Packaging Center of Excellence, Medical Devices at Johnson & Johnson. He is an accomplished leader with a broad base of experiences in sterile barrier package design, with a track record of implementing innovative packaging systems and packaging strategies that elevate the quality, compliance and customer-delight experiences across Johnson & Johnson medical devices packaging systems. Career experiences include package structural design with a focus on sterile barrier packaging systems, package assembly, sealing and labeling, design verification, design validation, project management, program management, new facility and equipment installation, process qualification, standards and regulation compliance, risk mitigation and cross-functional team development. 

Panel Moderator: Systemic Approach to Seal Strength

Geoff Pavey, Technical Fellow
Oliver Healthcare Packaging

Geoff Pavey is Technology Manager and Technical Fellow for Oliver-Tolas Healthcare Packaging with responsibility for technical service and support, and material and product development.   Geoff has significant experience and knowledge of sterile barrier system packaging materials and design and provides application consultation services to customers.   He has a packaging degree and 25+ years’ medical device industry experience, and is actively involved in several medical industry committees including the Institute of Packaging Professionals (IOPP), ASTM International, the Association for the Advancement of Medical Instrumentation (AAMI-ISO 11607) and the Sterile Packaging Manufacturers Council. 

Panel: Systemic Approach to Seal Strength

Michael Scholla, Global Director, Regulatory Standards
DuPont Protection Solutions

Mike is the Global Director, Regulatory & Standards and Medical Packaging Fellow for the DuPont Medical and Pharmaceutical Protection business within DuPont Protection Systems. He is actively involved in numerous industry groups, including the Association for the Advancement of Medical Instrumentation (AAMI) where he has served on the Board of Directors for over twelve years and was elected Chair in June 2014. He currently serves as Immediate Past Chair. He also serves on the AAMI Foundation Board. He serves as co-chair of the Sterilization Standards Committee which is the US Mirror Group for ISO TC198 and a former member of the Committee on Standards Strategy. Mike is the Convener of ISO TC198/WG7 on Medical Packaging, responsible for the globally harmonized standard EN ISO 11607 and guidance EN ISO TS 16775; a member of the editorial board for Pharmaceutical and Medical Packaging News; and a 30-year member of the American Society for Microbiology. Mike has a diverse research background and is credited with six U.S. patents and more than 60 published papers and articles.

Prior to joining DuPont in 1988, he was a member of the faculty at the University of Memphis. Mike earned BS and MS degrees in microbiology from the University of Central Florida and was awarded the Ph.D. from North Carolina State University. In 1994, he received the UCF College of Health and Public Affairs Professional Alumni Achievement Award. He was honored again by the Burnett College of Biomedical Sciences in 2006. He received Standards Developer Awards from AAMI in 2010 and 2015.

Presentation: Breaking News! Revision of ISO 11607

Randy Troutman; Director of Sales, Marketing and Technology
Printpack Medical

Randy Troutman is Director of Sales, Marketing and Technology at Printpack Medical. He has an extensive background as a business development professional in R&D, FDA requirements, medical devices, strategic negotiations and business process improvement. He has an MBA in Leadership and Business Management from Christian Brothers University and a Packaging Engineering Degree from the University of Wisconsin-Stout.

Moderating: Live Audience Interactive Polling Session

Sameer Upadhyaya, Head of Technology, Global Packaging Department
Genentech, a Member of the Roche Group

Sameer Upadhyaya is Head of Technology in the Global Packaging Development Department at Genentech, a member of the Roche Group, a position he has held for the past two years. Previously, he was Senior Principal Packaging Engineer at Medtronic CardioVascular, where he had been on the packaging engineering team since 2008. Prior to that, Sameer was Packaging/Labeling/Sterilization Engineer at W.L. Gore Associates for six years. Sameer has an MS in Packaging from Michigan State University.

Presentation: Let’s Make SBS Seal Strength Testing Really Easy!

Jennifer Van Mullekom, Associate Professor of Statistical Practice and Director, Laboratory for Interdisciplinary Statistical Analysis
Virginia Tech

Jennifer Van Mullekom is Associate Professor of Statistical Practice and Director of the Laboratory for Interdisciplinary Statistical Analysis at Virginia Tech. She is a statistical collaborator with a background in setting statistical strategy, procuring project funding and providing leadership to highly complex multidisciplinary statistical projects. Previously, at DuPont, Jennifer was a key statistician in the work behind the company’s Tyvek transition. She has been actively involved in the American Statistical Association’s Section on Physical and Engineering Sciences (SPES) since 1998 and has held various positions in the organization. Her statistical areas of interest include equivalence testing, regression modeling, response surface designs, mixed models and statistical engineering.

Presentation: Sample Size Strategic Planning and Optimization

Thierry Wagner, Regulatory Affairs Director EMEA
DuPont Medical and Pharmaceutical Protection

Thierry Wagner has spent nearly 30 years working for DuPont in its polyester films and nonwovens businesses in a variety of assignments ranging from process development and project management to operations and business management. He is chairman of the board of the Sterile Barrier Association (SBA), member of the Parenteral Drug Association (PDA) and actively involved in various ISO and CEN technical committees on medical and pharmaceutical packaging like ISO TC198 “Sterilization of Health Care Products—Packaging” (ISO 11607), CEN TC102 “Sterilizers for Medical Purposes—Packaging” (EN868), and ISO TC76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use”. Thierry is also a member of ISO/TC 210 in charge of ISO 13485 and ASTM Committee F02 – Flexible Barrier Packaging and of the CEN ABHS (Advisory Board for Healthcare Standards-Europe). 

Thierry Wagner earned a master’s degree in mechanical and process engineering from ETH Zürich in Switzerland.  He is a featured speaker at international conferences and seminars on medical and pharmaceutical packaging regulatory aspects.

Presentation: Breaking News! Revision of ISO 11607

Patrick Weixel, Acting Deputy Office Director of Patient Safety and Product Quality, Center for Device and Radiological Health, Office of In Vitro Diagnostics and Radiological Health
U.S. Food and Drug Administration

Patrick Weixel is Acting Deputy Office Director for Patient Safety and Product Quality at the Food and Drug Administration’s CDRH/Office of In Vitro Diagnostics. He received his BS from Frostburg State University in 1989. He has been with the FDA for more than 25 years. He started as an investigator and primarily conducted medical device inspections. In 1999, he accepted a position in the Center for Device and Radiological Health (CDRH). Weixel’s primary responsibilities included the review of establishment inspections reports and regulatory, classification of recalls, participate in training courses and to conduct reviews that involved sterilization or packaging issues. He was also involved in assignments dealing with reprocessing of single use devices. He then became a Postmarket Team Leader within the Division of Radiological Health/Office of In Vitro Diagnostics and Radiological Health, evaluating inspection reports to determine if the device manufacturer is complying with the quality system regulations. 

Presentation: The FDA Perspective: Voluntary Recalls and Deficiencies for Package Processes

“I like the diversity of age and experience between the speakers. Both the old and wise, and young and bright, perspectives are very valid.”

–Previous HealthPack Attendee

See more praise for HealthPack.

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