Program

AGENDA                           PRESENTERS

Tuesday, March 6

2 - 3:30 p.m. Preconference Roundtable: Upcoming Requirements in ISO 11607-1 to Demonstrate Opening and Dispensing Aseptically (General Conference Room)
4 - 5 p.m.  IoPP Medical Device Packaging Technical Committee Meeting (General Conference Room)
5 - 7 p.m Welcome Reception (Kansas City Marriott Downtown)
 

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Wednesday, March 7

7 - 8:15 a.m. Registration and Breakfast Buffet
 

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8:15 - 8:30 a.m.  Welcome/Opening Remarks
Jim George, Conference Director
8:30 - 9:15 a.m.

Keynote
Industry 4.0: Considerations for Packaging

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

The next industrial revolution is here—it’s the digitization of industry. It affects the entire value chain, from packaging to customer, it’s global in scope and it will impact both small and large companies. It’s called Industry 4.0, and it’s already making early appearances in the medical device sector.

MDMs will be looking to Industry 4.0 for data analytics to align packaging operations with the business goals of reduced time-to-market, global supply chain visibility, product demand management and flexibility, total landed cost, compliance and traceability for their high-value devices. Manufacturers that do these operations best in the digitization of industry will have the best chance of becoming preferred suppliers to their end users. Whether you want to be on the leading edge of this this new world of manufacturing or simply want to do a good job of keeping pace, this presentation will provide you the essential need-to-knows of Industry 4.0, and where and how it impacts packaging.

9:15 - 10 a.m.

Smart Packaging—Technology that Adds Value
Dan Burgess, Packaging Engineering Fellow, Exploratory Packaging Group, Boston Scientific

RFID and related technologies have been around for many years, but advances in techniques used to manufacture components enable reduced cost, greater range of application and lower profiles. This means that functionality which previously may have been seen as a benefit but deemed too expensive or bulky, now can be incorporated into existing components without a lot of added weight or bulk. Learn how to identify the value smart packaging functions can provide, when to choose an off-the-shelf option versus developing your own solution and how to select appropriate vendor partners.

10 - 10:30 a.m.

Networking Break

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10:30 - 11:30 a.m.

Breaking News! Revision of ISO 11607
Michael Scholla, Global Director, Regulatory Standards, DuPont Protection Solutions
Thierry Wagner, Regulatory Affairs Director EMEA, DuPont Medical and Pharmaceutical Protection

Great breaking information on revisions to ISO 11607 is coming out of the WG7 meeting the week prior to HealthPack. ISO 11607-1 and 2 are moving through the five-year revision cycle process. The European Medical Device Regulation was published during this cycle, and it makes specific references to packaging.  As a result, changes have been made to the standard to address specific requirements in the MDR. The Draft International Standard Ballot closed on December 11, 2017, with comments from all the mirror groups then distributed in advance of the meeting that begins Feb. 27, 2018. Get yourself up to date with two international subject experts on this critical standard, and learn the implications and requirements for packaging.

11:30 a.m. - 1 p.m. Lunch & Exhibitor Showcase
 

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1 - 2 p.m. 

The FDA Perspective: Voluntary Recalls and Deficiencies for Package Processes
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

In this enlightening session, get insights from the FDA’s inspection observations, as well as the “why” of voluntary recalls with medical device packaging. The discussion will also focus on trends in deficiencies noted as a result of audited package processes, trends in recent recall data and insight on future FDA focus and direction on activity related to medical device packaging. Come prepared with your questions!

2 - 2:30 p.m. IoPP Medical Device Packaging Technical Committee Update
Updates from committee and sub-committee chairs
2:30 - 3 p.m. Networking Break
 

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3 - 4 p.m. 

Voice of the Customer—Nurses & Technicians Panel

A panel of local operating room nurses and medical technicians reviews medical device packages for examination. (Led by IoPP’s Medical Device Packaging Technical Committee.)

 

4 - 4:45 p.m.  Nurses & Technicians Panel Q&A with Conference Attendees
5 - 7 p.m. Networking Reception in Exhibitor Showcase Area
 

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Thursday, March 8
7 - 8:15 a.m. Breakfast Buffet
 

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8:15 - 9 a.m.

Six Steps to Successful Remediation
David DiVaccaro, Principal, DiVaccaro Consulting Group

Remediation can be a great opportunity to set up your company for future success. This presentation will help you establish a winning process to get the most out of your remediation effort, from understanding the gaps to developing procedures and then executing them. This talk also will emphasize the need to understand relationships and resource/capital commitments and to establish key partnerships. In addition, learn tips for addressing FDA 483.

9 - 9:45 a.m.

Live Audience Interactive Polling Session
Moderated by Randy Troutman; Director of Sales, Marketing and Technology; Printpack Medical

This is becoming one of HealthPack’s most popular sessions! Real-time polling will be done on topics of interest to the medical device packaging community.

9:45 - 10:15 a.m.

Networking Break

 

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10:15 - 11 a.m.

Sample Size Strategic Planning and Optimization
Jennifer Van Mullekom, Associate Professor of Statistical Practice and Director, Laboratory for Interdisciplinary Statistical Analysis, Virginia Tech

A good strategy and process for proving package performance starts with knowing your objective and thoroughly understanding your process or experimental set up. Jennifer, who at DuPont was a key statistician in the work behind the company’s Tyvek transition, will address experimental strategic planning. Her presentation will emphasize setting objectives, translating objectives into the appropriate statistical test, understanding the impact of sources of variability and performing calculations for power and sample size. This talk will weave in plenty of packaging examples and case studies.

11 - 11:30 a.m.

Material Selection in Flexible Packaging
Dhuanne Dodrill, President, Rollprint Packaging Products

The myriad of choices available when designing a flexible medical device package can be overwhelming. This presentation will explore the properties of a wide range of building blocks that can be used to build a structure and provide guidance on the right questions to ask to help eliminate surprises.

11:30 - 1 p.m.  Lunch & Exhibitor Showcase
 

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1 - 2 p.m.

Panel Discussion: Systemic Approach to Seal Strength
Moderator
Rod Patch, Senior Director, Packaging Center of Excellence, Johnson & Johnson

Panelists
Geoff Pavey, Technical Fellow, Oliver Healthcare Packaging
Scott Levy, Packaging Engineer, DDL
Thomas McNabb, Principal Project Engineer, Medtronic Neurovascular
Nick Layman, Staff Franchise Packaging Development Engineer, Ethicon

This engaging session will bring together perspectives on achieving consistent seal strength from many different, but critical, corners of the industry.

2 - 2:45 p.m.

Let’s Make SBS Seal Strength Testing Really Easy!
Sameer Upadhyaya, Head of Technology, Global Packaging Department, Genentech, a Member of the Roche Group

This presentation will highlight the data and findings from a new collaborative industry study focused on understanding two key seal strength variables: different seal widths and different test coupon lengths.

2:45-3 p.m.   Conference Wrap-Up and Prize Drawing
 

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3 p.m. Adjourn

“I love the panel with the nurses and technicians, and hearing the different local perspective each year. It’s very enlightening.”

–Previous HealthPack Attendee

See more praise from HealthPack attendees.

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