Language: EN - DE
DOUBLE WORKSHOPS OPPORTUNITY: Evolution in Technology and Regulation of Medical Device Packaging: challenges and trends- June 5/6, 2018

Evolution in Technology and Regulation of Medical Device Packaging: challenges and trends.

The seminar will be conducted in German language mainly.

Brian McEvoy, STERIS

Qualified as a Microbiologist (University of Manchester, UK) and subsequently educated to MBA level at Coventry University, UK. Current undertaking a PhD in Microbiology. Having spent the last seventeen years in the healthcare sterilization industry working for Isotron, then Synergy Health and now STERIS, in previous roles including Quality Engineer, Laboratory Manager, EO Plant Manager, General Manager Ireland and Commercial Director Europe. Core competences include terminal sterilization technology, facility and team management, project management, business leadership and microbiology.  

Current role at STERIS AST encompasses technology leadership, strategy development and deployment across all technology platforms, both gaseous (Ethylene Oxide and Vaporized Hydrogen Peroxide) and radiation (Electron Beam, Gamma and Xray radiation). Role also involves innovation, process optimization and new technology development. 

Reiner Eidenberger, STERIS

Reiner Eidenberger is managing director for the STERIS AST – Allershausen facility, in Germany. With a degree in applied physics and an MBA in Systems Management, Reiner joined the company in 1991 as technical manager before moving into his current role in 1994.

Reiner is an active member of several industry working groups including the German Medical Technology Association (BVMed), Medical Standards Committee (NAMed) at the German Institute for Standardisation, DIN.

With over 25 years’ experience and involvement with industry associations, Reiner has a wealth of knowledge pertaining to the sterilisation requirements of the medical device industry.

Kevin Zacharias, Oliver Healthcare Packaging

Kevin Zacharias is the Global Technical Director at Oliver Healthcare Packaging, with headquarters in Grand Rapids, Michigan (USA). In this role, Kevin is responsible for product development and technical service.

Kevin earned his undergraduate degree in Packaging from Michigan State University, and his MBA from Butler University. With more than 25 years of experience in medical device packaging, his expertise is in package design, testing & validation, and product development.

Prior to joining Oliver, Kevin was the Manager of Packaging Development at Baxter Healthcare, and a Packaging Engineer at Roche Diagnostics.

Thierry Wagner, DuPont

Thierry Wagner has spent the past 25 ­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 a member of the board of the Sterile Barrier Association (SBA) and a member of various ISO and CEN technical committees on medical and phar­ma­ceu­tical packaging. He also represents DuPont on ASTM F02 Committee – Flexible Barrier Packaging. 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 packaging regulatory issues.

Nicole Kaller, DuPont

Nicole Kaller has a diploma in Packaging Technology and has been working for DuPont Luxembourg as Technical Support Representative for Medical & Pharmaceutical Protection since 2008.

She provides technical and application support to Medical Device and Sterile Packaging Manufacturers and works on Tyvek© Medical Packaging related global projects and quality benchmarking subjects.
Nicole Kaller is a regular speaker at international conferences and seminars on medical packaging technical aspects.

Jan Havel, TÜV-SÜD Product Service, Medical and Health

Is Global Director of a team of experts in the field of sterilization-, packaging design- and sterile packaging process validation, validation of the design of reprocessing instructions for medical devices and of experts in the field of biological and microbiological safety of medical devices. Besides his leading function Dr. Havel is trainer of the mentioned topics as well as for risk management and usability of medical devices. He is an EN ISO 13485 /9001 CMDCAS/MDD Auditor and active member of the standardization committee ASTM F02 on Primary Barrier Packaging. In the context of NAKI he is involved in the definition of common specifications for the new MDR.

Laura Bix, Michigan State University

Dr. Bix is the Associate Director at the School of Packaging at Michigan State University and an Adjunct Associate Professor at Clemson University. Her work focuses on quantifying the interface between people and packaging with the ultimate goal of improving health outcomes. Her unique vein of inquiry was recognized in 2008 by Medical Devices and Diagnostics Industry magazine, when she was named one of the 100 most notable people in the medical device industry. Since 2009, she has served on expert panels convened by the US Centers for Disease Control and Prevention (CDC) as part of their medication safety programs. From 2012-2014, Dr. Bix served on a national panel formed by the Gerontological Society of America (GSA) and the Consumer Healthcare Products Association (CHPA) that examined behaviors related to medication use in older adults. More recently, she served as an invited expert on panels convened by the US Food and Drug Administration that investigate the role of packaging in fighting the current crisis affiliated with opiate use and abuse. Her approach to multi-disciplinary endeavors and the value that she places on unique collaborations have been lauded. Awards she has received include a Kappa Phi Excellence in Interdisciplinary Scholarship Award (MSU Chapter) and her leadership skills have been recognized with an appointment as an MSU fellow for the CIC Academic Leadership Program. Work from her group has been published or cited by numerous publications, including: The Proceedings of the National Academy of Sciences of the US, PLoS One, Consumer Reports and Men’s Health.​

Heidi Vanheerswynghels, Videojet

Heidi Vanheerswynghels is the EMEA sales manager Life Science at Videojet Technologies carrying responsibility for all medical and pharmaceutical end user business within EMEA. Taking a central role in sales growth with a dedicated team, she also works closely with the Videojet marketing team building and coordinates with the OEM organization taking care of the packaging line manufacturers and product development teams.

Heidi has been focusing on pharma and medical business for more than 13 years and brings significant experience in the medical device and pharmaceutical packaging industry having held various roles as Global Strategic Account Manager Pharma and Key Account Manager Healthcare in addition to speaking four languages fluently (Dutch, English, French and German) and has a basic knowledge of Italian. She obtained a BA from the University College Ghent (UCG) at the Faculty of Business and Information Management.

Luc van de Vel, MULTIVAC

Luc van de Vel is the Vice President of the Medical and Pharmaceutical Division at MULTIVAC in Wolfertschwenden. He has more than 20 years of experience within the packaging and pharmaceutical industry. Prior to joining MULTIVAC in 2008 he has worked for Janssen Pharmaceutica, Pester Pac Automation and as a consultant with Amgen, Schering Plough and Innogenetics. 

Mike Bachmann, Anecto

Mike Bachmann is International Business Development Lead at Anecto. He represents Anecto to testing services clientele throughout Europe.
Mike has worked in the field of medical devices and packaging for almost a decade. Through his experience, he acts as a resource on ISO 11607 and other internationally recognized standards. He also provides direct advisory support to medical device manufacturers on issues relating to regulatory compliance and testing. Mike is fluent in English and German.

Noel Gibbons, Anecto

Noel Gibbons is the Lead Programme Manager for Anecto. He is an engineer with experience in a variety of areas, including package testing, package integrity testing, quality and international test standards.
Noel has presented seminars internationally on Medical Device & Pharmaceutical testing including the requirements of ISO 11607 and other test standards. He has also provided training on the requirements of ISO 11607 to companies throughout Europe.
He is a member of the following:

  • External expert committee member for the NSAI on ISO 11607
  • ASTM Committee F02 on Flexible Barrier Packaging
  • ASTM Committee D10 on Packaging
  • Institute of Packaging Professionals