On Demand Webinars*

Tyvek® Transition Results Support Functional Equivalence. What’s Next for You?
Original Broadcast: October 6, 2016
Time: 8:00am - 9:00am PDT | 11:00am - 12:00pm EDT | 4:00pm - 5:00pm BST | 5:00pm - 6:00pm CEST
Show Archive Date: October 6, 2015
Speakers: Bruce A. Yost, Michael H. Scholla, Karen Polkinghome, Marget (Meg) Pyers
Moderator: Daphne Allen

DuPont completed submissions of all Regulatory Reports for the Tyvek® Medical Packaging Transition Project (MPTP) through 1-year real-time aging in August 2015 and has been following up with face-to-face meetings with the U.S. FDA, Health Canada and five Notified Bodies in Europe. In this webinar, the team will share up-to-the-minute regulatory news; provide the latest data—including some 7- and 10-year accelerated aging package data; and discuss commercialization plans. Attend this webinar to get the latest information to help ensure that your organization is ready for the Tyvek® Transition.

German language webinar
Broadcast Date: November 12, 2015
Time: 2:00pm GMT | 3:00pm CET

DuPont Submission to U.S. FDA Fast Approaching The Finish Line—Are You Ready?
Original Broadcast: May 21, 2015
Time: 8:00am - 9:00am PDT | 11:00am - 12:00pm EDT | 4:00pm - 5:00pm BST | 5:00pm - 6:00pm CEST
Show Archive Date: May 21, 2016
Speakers: Bruce A. Yost, Michael H. Scholla, Karen Polkinghome
Moderator: Daphne Allen

In this webinar, the DuPont™ Tyvek® Medical Packaging Transition Project (MPTP) team will share the latest data and reports summarizing testing results across 100,000 packages from 55 medical device manufacturers globally. With about 80% of results in so far, the project is on track for submission to the U.S. FDA slated for this summer and commercialization beginning in the third quarter. Attend this webinar to get the latest information to help ensure that your organization will be ready.

German language webinar
Original Broadcast Date: June 18, 2015
Time: 2:00pm GMT | 3:00pm CET
Show Archive End Date: June 18, 2016

French language webinar
Original Broadcast Date: June 24, 2015
Time: 2:00pm GMT | 3:00pm CET
Show Archive End Date: June 24, 2016

A Medical Packaging Testing Case Study – The Impact of Sterilization and Transportation on Microbial Barrier Properties of Materials
Broadcast: March 18, 2015
Time: 3:00pm - 4:00pm CET | 2:00pm – 3:00pm GMT | 10:00am - 11:00am EDT | 7:00am - 8:00am PDT
Show Archive Date: June 24, 2016
Speaker: Nicole Kaller
Moderator: Daphne Allen

The loss of package integrity can have serious consequences ranging from costly product recalls to compromised patient safety. In the recent webinar “Can You afford a Packaging Failure” we learned about the importance of conducting an established testing and validation process as crucial steps to ensuring package integrity and helping to prevent healthcare associated infections (HAIs). It has been emphasized that systematic environmental conditioning and transportation testing and subsequent package integrity testing will detect issues with packaging before the product is introduced into the market.

This new webinar will demonstrate the importance of performing microbial barrier testing in addition to package integrity testing post sterilization and subsequent environmental conditioning and transportation testing during validation. Common package integrity tests are limited in their leak detection sensitivity; therefore a microbial barrier test will provide additional and more detailed input helping to judge overall integrity and safety of a sterile package, while responding to regulatory requirements in EN ISO 11607.

The webinar will present extensive data and discusses key findings from a study conducted to evaluate the performance of standard chevron pouches made with either DuPont™ Tyvek® 1073B, Tyvek® 2FS™ or one of four commonly used medical-grade papers. The pouches have been subjected to microbial barrier testing before sterilization and after sterilization (ETO or Gamma) and transportation testing.

 

Previous Live Chats*:

Regarding the White Paper "Medical Packaging Study - The Impact of Sterilization and Transportation Testing on the Microbial Barrier of Different Materials"

Date: Thursday, February 25, 2016
Time: 10:00am - 11:00 EST | 7:00am - 8:00am PST | 3:00pm - 4:00pm GMT | 4:00pm - 5:00pm CET

Do you know why and when to test microbial barrier?

How do the standards address microbial barrier?

How does microbial barrier play a role for risk mitigation in terms of sterility maintenance of a package?

Get answers to these questions and more by attending our 'invitation only' live chat event! You will walk away with knowledge of the benefits of microbial barrier testing as well as the importance of thoroughly established test or validation plans!

Nicole Kaller, DuPont Packaging Engineer Tyvek® and author of the white paper "Medical Packaging Study - The Impact of Sterilization and Transportation Testing on the Microbial Barrier of Different Materials,"* will be on hand with her colleagues, Regulatory Affairs Director, Thierry Wagner and Packaging Sciences and Customer Applications Leader, Jane Severin, to answer your most pressing questions.

*This white paper currently resides in the Validating & Testing tab of the Resources section of the Community.

Live Chat Regarding the Medical Packaging Transition Project!

Date: July 22, 2015
Time: 11:00am - noon EDT | 8:00am - 9:00am PDT | 4:00pm - 5:00pm BST | 5:00pm - 6:00pm CEST

DuPont has completed essential package data indicating Functional Equivalence between Current Tyvek® and Tyvek® Transition material and is on track to begin commercial sales in October.

Medical packaging professionals and members of the Medical Packaging Community were invited to a live chat to get their Medical Packaging Transition Project questions answered by the following experts: Karen Polkinghorne, Packaging Engineer & MDM Specialist; Eric Schmohl, Customer & Application Support Manager; Michael H. Scholla, Ph.D., Global Regulatory Director; Thierry Wagner, Regulatory Affairs Director - Europe Middle-East & Africa; and Bruce A. Yost, Ph.D., Global Technical Director.

Live Chat with Nicole Kaller,Thierry Wagner, and Eric Schmohl

Date: July 31, 2014
Time: 10:00am - 11:00am EDT | 7:00am - 8:00am PDT | 3:00pm - 4:00pm BST | 4:00pm - 5:00pm CEST

On March 26th, 2014 attendees of the Webinar "Can You Afford a Packaging Failure?" gained insight on defining the right strategy for medical packaging testing, including transport simulation. As a follow up, the following white paper "Medical Packaging Study – Reducing the Risk of Failure through Performance Testing of Packaging Made from Various Materials,"** presented extensive data and discussed key findings from a study conducted to evaluate the performance of standard chevron pouches made with either DuPont™ Tyvek® 1073B, Tyvek® 2FS™ or one of five commonly used medical-grade papers.

On July 31, 2014, Daphne Allen, Editor of Pharmaceutical and Medical Packaging News interviewed Nicole Kaller, author of the white paper "Medical Packaging Study – Reducing the Risk of Failure through Performance Testing of Packaging Made from Various Materials," and Packaging Engineer Tyvek® - Europe, Middle-East & Africa, DuPont Medical and Pharmaceutical Protection, via live chat. Attendees of the live chat had the opportunity to ask questions of their own. Thierry Wagner, Regulatory Affairs Director EMEA, and Eric Schmohl, Customer & Application Support Manager EMEA DuPont Medical & Pharmaceutical Protection, joined the chat to answer additional questions.

**This paper currently resides in the Medical Packaging Design tab of the Resources section of the Community.

On Demand Webinar Speakers

Nicole Kaller
Packaging Engineer – Europe, Middle East and Africa
DuPont Medical and Pharmaceutical Protection
Nicole Kaller has been working for DuPont Luxembourg as Packaging Engineer for Medical & Pharmaceutical Protection since 2008. She provides technical and application support to Medical Device Manufacturers and works on Tyvek® Medical Packaging related projects and quality benchmarking subjects. Nicole frequently speaks at international conferences and seminars on the topic of packaging and technical studies for the healthcare industry.
 
Leslie Love MDM,
Specialist DuPont Protection Technologies
Leslie Love supports DuPont medical device and pharmaceutical customers in the areas of new business development, and application and technical support for Tyvek® based sterile barrier packaging. Leslie is based north of the Philadelphia, PA area and has spent the better part of her 30 year packaging career working in both primary and secondary healthcare packaging. Prior to DuPont, Leslie served in various sales and marketing leadership roles responsible for overseeing sales teams, market and product development and technical support functions in sterile barrier systems and protective packaging. Earlier in her packaging career she also worked in quality, production planning and estimating roles for printing and converting of sterile barrier packaging and labeling.
 
Karen Polkinghorne
Packaging Engineer & MDM Specialist
Karen began her career as a packaging development engineer designing and testing medical packaging for orthopedic implants and surgical instrument trays. She has also worked as a business development manager for a major sterile packaging manufacturer and been a part of the DuPont Medical Packaging team for the past seven years. During her career, Karen has specialized in medical package design, equipment qualification, package and process validation, project management and materials marketing. She holds a bachelors degree in Packaging from Michigan State University and an MBA from the University of Colorado.
 
Roseann C. Salasin
Global Marketing Director
Salasin brings a wealth of experience to this leadership role, gained through a variety of assignments in operations, sales management and marketing during her 30-year career at DuPont.

She is a member of the Association for the Advancement of Medical Instrumentation (AAMI), a founding member of the Healthcare Plastics Recycling Council (HPRC) and a member of the HPRC steering committee.

Salasin earned a bachelor’s degree in accounting, with a minor in finance, from St. Joseph’s University. She is the recipient of the TLMI Environmental Award and the Flexographic Technical Innovation Award, as well as DuPont Awards for Marketing Excellence, Engineering Excellence and Sustainable Growth.
 
Michael H. Scholla,
Ph.D. Global Regulatory Director
Scholla is actively involved in numerous industry groups, including the Association for the Advancement of Medical Instrumentation (AAMI) where he serves as Chair of the Board of Directors, co-chair of the Sterilization Standards Committee and is a member of the Committee on Standards Strategy. He has served on the AAMI board of directors beginning in 2000. Scholla is also the Convener of ISO TC 198 WG7 on Medical Packaging, responsible for globally harmonized standard EN ISO 11607 and its guidance document EN ISO TS 16775. He is a member of the editorial board for Pharmaceutical and Medical Packaging News and a 30-year member of the American Society for Microbiology.

Scholla 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.

Scholla earned a bachelor’s and master’s degree in microbiology from the University of Central Florida and was awarded a Ph.D. from North Carolina State University. In 2006, he received the Alumni Professional Achievement Award from the Burnett College of Biomedical Sciences at the University of Central Florida and in 2010 he received the Standards Developer Award from AAMI.
 
Jennifer H. Van Mullekom, Ph.D.
Senior Consulting Statistician


A member of DuPont’s Applied Statistics Group, Van Mullekom provides statistical leadership for the Tyvek® Medical Packaging Transition Project (MPTP) in the areas of product development, commercialization and regulatory.

She has been actively involved in the American Statistical Association’s (ASA’s) Section on Physical and Engineering Sciences (SPES) since 1998, holding various positions, including Publicity Chair, Marquardt Speaker Chair and Program Chair. In 2014, Van Mullekom was elected as SPES Section Chair for the second time. She also co-developed the ASA’s course titled “Effective Presentations for Statisticians.”

Van Mullekom earned undergraduate degrees in mathematics and mathematics education from Concord University. She received a master’s degree and Ph.D. in statistics in 1995 and 1998, respectively, from Virginia Tech. Van Mullekom is a DuPont Associate Fellow and a Six Sigma Master Black Belt. She holds three U.S. patents.
 
Thierry Wagner
Regulatory Affairs Director
Europe, Middle-East & Africa
DuPont Medical and Pharmaceutical Protection
With a Master of Science in mechanical and process engineering from ETH Zürich in Switzerland, Thierry Wagner has 25 years of experience in various positions in Polyester Films and Nonwovens of DuPont de Nemours. 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 packaging and of ISO/TC210 in charge of ISO13485. He also represents DuPont on ASTM F02 Committee – Flexible Barrier Packaging.

Thierry Wagner is a regular speaker at international conferences and seminars on medical packaging regulatory aspects.
 
Bruce A. Yost, Ph.D.
Global Technical Director

During his 28-year career with DuPont, Bruce has worked in a variety of technical and management roles, including product, process and application development, as well as market and business development.

In his current role, Bruce is responsible for all technical and operational aspects of the transition of DuPont™ Tyvek® 1073B and Tyvek® 1059B to manufacturing lines that use the latest DuPont flash-spinning technology, including product and process development and protocol testing execution.

Yost earned a bachelor’s and master’s degree in mechanical engineering from the University of Delaware and was awarded a Ph.D. in mechanical engineering from the University of Delaware. He is an Innovation Process Champion at DuPont and holds four patents.

 
Margaret (Meg) Pyers
Global Marketing Director
DuPont Medical and Pharmaceutical Protection

Meg has served in a variety of marketing, strategy, and product management positions, both within and outside of DuPont. Her sterile packaging experiences include DuPont’s Diagnostics business, a leader in providing pathogen testing solutions to the food and pharmaceutical industries. Prior to DuPont, Meg worked with Advanced Electron Beams, a company which offered in-line sterilization solutions to the food packaging and pharmaceutical industries.

Meg has a Bachelor of Arts degree from Lehigh University and a Masters of Business Administration from the Darden School of Business at the University of Virginia.

 
Moderator:
Daphne Allen, Editor
Daphne Allen is editor of Pharmaceutical & Medical Packaging News, a publication serving packaging professionals responsible for pharmaceuticals and medical devices. Allen has been covering the industry for more than 14 years.
 

 
Previous webinars include*:
  • Tyvek® Transition Results Support Functional Equivalence. What’s Next for You?
    German Language
  • A Medical Packaging Testing Case Study – The Impact of Sterilization and Transportation on Microbial Barrier Properties of Materials
 
Announcing extensive content in the Community, including:
  • Member poll on evaluating packaging seal strength
  • White Paper: Medical Packaging Study – Reducing the Risk of Failure through Performance Testing of Packaging Made from Various Materials
Visit the Community and experience this content today!