Webinars
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Webcast: U.S. FDA Agreed Upon Protocol Testing Underway for Tyvek® Transition Project Sponsored by: The DuPont team will provide an update on the Tyvek® transition project including the U.S. FDA and Phantom Protocol package configurations and sterilization details, the latest testing results and transition material properties. The team will also discuss updated global regulatory guidance, project timelines and when the new material will be available for controlled sales.
Technology Innovation in Healthcare Supply Chain Management
__________________________________________________________________________________________________ What is ASTM? __________________________________________________________________________________________________ Protecting High-Value Temperature-Sensitive Shipments __________________________________________________________________________________________________
Innovative Flexible Packaging Applications for Healthcare Date: November 29, 2012 Sponsored by:
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Reduce, Recycle, Recover: Redefine your sterile barrier system in a flexible footprint Date: November 15, 2012 Approximately 5.2 million tons of waste is generated by the healthcare industry each year. Medical device and pharmaceutical manufacturers develop packaging systems that protect their products and support patient safety yet by nature contribute to this waste stream. We recognize this is a complex issue, but believe there is an opportunity to balance these objectives. Attendees will:
Click Here to view biographies. __________________________________________________________________________________________________
Supply Chain Week Events--Now On Demand! Register today to hear these exclusive Webcasts! "FDA’s Unique Device Identifier Initiative" AIM North America has formed a subcommittee to discuss FDA’s pending Unique Device Identification (UDI) initiative and offer recommendations for standards addressing interoperability and business models. During this Webcast AIM North America's speaker panel, which includes Ken Koldan, Chair for the UDI Initiative and New Business Development Manager, FLEXcon; Clive Hohberger of The BloodCenter of Wisconsin, and Jackie Rae Elkin, Global Process Owner of Standard Product Identification at Medtronic, will discuss: · Define UDI and its importance to the US healthcare system.
Susan Li, Manager of UPS Healthcare Strategy, discusses the steps manufacturers of pharmaceuticals and medical devices can take to protect them from hazards along the supply chain. She will also explore some of the common and not-so-common pitfalls.
Gary M. Hutchinson, President of Modality Solutions LLC, and Daniel J. Littlefield, Principal of Modality Solutions LLC, discuss sustainability considerations when developing thermal packaging and logistics programs for the biopharmaceutical industry. Modality Solutions provides engineering/logistics consulting, systems integration, and simulation laboratory services from discovery through distribution.
"DuPont Medical Packaging Transition Project (MPTP) - Progress Report" Attend this webcast for an update on the significant progress that has been made since DuPont announced the MPTP in June 2011. We'll share data from process and product development testing on functional equivalence. The Phantom Protocol and Product Stewardship efforts will be detailed. You'll hear updates on guidance we have received from regulatory bodies from around the world. And, we'll discuss what's ahead, including commercialization plans – and timing. "Current Events in Healthcare Packaging" Hear John Bamberger, North American Regulatory Affairs Manager for DuPont, review the latest events in healthcare. * Current State of U.S. Healthcare Reform “DuPont Tyvek in 2012 and Beyond” Dr. Michael Scholla and members of the DuPont Global Medical Packaging Team update attendees in on progress in the transitioning of Tyvek 1073B and Tyvek 1059B to manufacturing lines that use its latest flash-spinning technology. "Fundamentals of Medical Package Engineering and Design" Karen Polkinghorne, Packaging Engineer & MDM Specialist for DuPont Medical & Pharmaceutical Packaging, discussed how to select the right package configuration for your product, including: * Design considerations for pouches, trays and lids, and flexible 3-dimensional (FFS) packages. "An Introduction to DuPont Tyvek" * Background information on product development. Sponsored by:
Duration: 1 Hour On-Demand Web event This webcast, featuring HP and Nosco, gives you an exclusive look into the future of Digital Print for Packaging – Labels, Cartons, and Flexible Packaging. Digital is stepping up, and you’ll get a sneak peek into how it can impact pharmaceutical packaging. HP will take you through some of the most revolutionary innovations and product releases for Digital in history. Nosco will then show you how these can be utilized for pharmaceutical packaging. Speakers:
Packaging has become a strategic issue as many companies are facing mounting pressure to achieve cost reductions and sustainability goals. Whether you are designing a pill bottle or a medical device sterile barrier, packaging configurations directly impact every link of the supply chain – from inbound materials to storage and distribution. With material and logistics costs on the rise, there is a tremendous opportunity to optimize both primary and secondary packaging. In this exclusive webcast from Pharmaceutical & Medical Packaging News, packaging experts from Chainalytics, a leading provider of supply chain intelligence, analytics, and advisory services, will discuss how supply chain packaging optimization can help you realize productivity, efficiency, and sustainability gains. Specifically, Chainalytics will explain how physical packaging attributes – such as dimensions, weight, design, unitization and containerization – affect shipping and logistics costs. In addition, Chainalytics will share conditions to look for in your distribution system to help you identify packaging improvement opportunities.
8 Ways to Save with Combination Packaging Combination packaging can save you money without ever compromising quality. This webcast takes you through some of the simple ways you can you can go lean in 2012 by reducing downtime, increasing packaging line speeds, reducing inventory and obsolescence and maximizing your floor space all the while saving you money in the long-run. Combination Packaging merges multiple printed packaging components, including labels and cartons, and labels and inserts, to get extra copy space and improve your production processes.
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Jan Gates 
Vince Pusateri 
Dave Vaczek 
Now Archived!
Packaging Test Methods for Validation of Sterile Barrier Materials
Webcast Duration: 60 minutes
The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge to make decisions regarding which tests should be used to validate their sterile barrier system. By focusing on specific tests as outlined in ISO11607, each individual will have the opportunity to view actual test methods, determine appropriate test samples and identify pros and cons to each method. Some of the methods viewed will consist of Bubble Emission ( ASTM F2096), Microbial Ranking (ASTM F1608), Burst Testing (ASTM F1140), Seal Strength Testing (ASTM F88), and Dye Migration (ASTM F1929).
Speaker:
Wendy Mach
Packaging Section Leader
Nelson Laboratories, Inc.
Moderator:
Dave Vaczek
Senior Editor
Pharmaceutical & Medical Packaging News
Sponsored by:
Now in our Archives: Get A Bodyguard For Your Packaging
Your products are at risk. Protect them through innovative security features that act as Bodyguards against counterfeiters. Learn how to combine technologies such as 2D Serialized Barcodes, RFID, and a new class of anti-counterfeiting technology called SignaKey to provide you with the highest degree of protection you require.
Duration: 1 Hour On-Demand Web event
Speakers:
Scott McFall
Security Packaging Advisor
Nosco
Greg Davis
Engineering Manager / ILS Solutions
Nosco
Moderator:
Daphne Allen
Editor
Pharmaceutical & Medical Packaging News
Sponsored by:
Register Today!
On-Demand Webcast! An Introduction to DuPont Tyvek
Duration: 1 Hour
We’ll share an overview of Tyvek® for medical packaging applications, including:
- Background information on product development
- Product attributes and benefits review
- Technical information and data
Expert Speaker: Jose R Arevalo
Business Development Manager, MDM Accounts & Latin America
DuPont Medical and Pharmaceutical Protection
Sponsored by:
Register Today!
Now in our Archives: Trends in Orthopedic Device Packaging
Packaging professionals from leading orthopedic device manufacturers will join PMP News Editor Daphne Allen to discuss some of the unique challenges associated with packaging orthopedic devices. Trends in end-user needs (at the hospital, clinic, or practitioner level), innovation, sustainability, cost control, and universal packaging will be discussed, as will regulations and standards that are driving change.
Webcast Duration: 60 minutes
REGISTER TODAY!
Speakers:
Rod Patch
Formerly WW Packaging Manager, DePuy Orthopaedics, now Franchise Packaging Development Manager,
Ethicon Endo-Surgery
Sarah Grare
Director of Packaging Innovation
Stryker Orthopaedics
Scott Hall
Manager, Package Engineering
Synthes
Moderator:
Daphne Allen
Editor
PMP News
Sponsored by:
Archived: Web Event: Understanding Braille Packaging Requirements
Nosco’s Braille Implementation Advisor, Rachel Greiner, and Director of Quality, Dick Leach, take an in-depth look at the current Braille standards around the world. Whether you are just beginning to implement Braille for a new international market or you want to transfer an existing product line that features Braille, Nosco’s experts will show you how to make it easier. In the upcoming webinar, Greiner and Leach will discuss how to develop your own quality standards that adhere to global Braille requirements.
On-demand
Webcast Duration: 60 minutes
Moderator:
Daphne Allen
Editor
PMP News
For more information about our moderator, please click here
Speakers:
Rachel Greiner
Braille Implementation Advisor
Nosco Braille
For more information about our speaker, please click here
Dick Leach
Director of Quality
Nosco Braille
For more information about our speaker, please click here
Web event: Data Integrity: Why Accuracy Is Critical in a Serialized Supply Chain
Date: June 22, 2011
Duration: 1 Hour
In pharmaceutical packaging, the integrity of data is essential when verifying the origin of manufacture when a suspect serialized number is read, regardless of whether or not the unique serial number is legitimate. This verification ability is the underpinning of any serialization initiative. Without it, items, cases, pallets and potentially an entire lot can be suspected as counterfeit. Supply chain events will inevitably happen – a manufacturer’s ability to identify what has occurred and respond depends on the accuracy of their data. This webinar will discuss the critical nature of packaging data, serialization’s effect on it, and how the convergence of data is impacting the supply chain.
Moderator:
Daphne Allen
Editor
Pharmaceutical & Medical Packaging News
Speaker:
Joseph Ringwood
Chief Operating Officer
Systech International
For more information about our speaker, please click here.
Sponsored By:
Archived: Validating Rotary Medical Sealers: Improving Process Control
Duration: 1 Hour
Packaging plays a vital role in ensuring the sterility of medical devices and instruments from manufacture to point of use. Applying effective heat seals to the package of terminally sterilized medical devices is a critical step to ensure the aseptic presentation of a product when it comes into contact with an end user or patient. This webinar will review the relevant regulatory standard for medical heat sealing and discuss some of the important considerations that should go into implementing an effective validation process. After covering some of the sealer design characteristics that ought to be prioritized when considering the traditional variables of time, temperature, and pressure, we will discuss a broader range of parameters - including visual defects, sealing band breakage, and label applications/confirmation - that can also impact package integrity. Ultimately, for a piece of heat sealing equipment to be fully compliant, total process control should encompass every step that affects the quality of the final product.
Click here to register for this free event.
Speakers: Ray Johnson Product Manager - Bag Closing, Bosch Packaging Technology Inc. For more information about our speakers, click here. |
 Mark Larson Sales Engineer - Bag Closing, Bosch Packaging Technology Inc. |
Meet the 4 Serialization Team! New Collaboration Enhances Supply Chain Safety!
On-Demand Webcast
Duration: 60 minutes
Nosco, Acsis, Cognex Corp., and Omega Design have joined forces to help pharmaceutical and life science companies prepare for serialization and electronic pedigree (ePedigree) requirements. PMP News editor Daphne Allen introduced the team during the live Webcast and interviewed its members to help attendees understand how the new alliance can work to ensure patient safety, prevent counterfeit drugs from entering the supply chain, and minimize diversion.
4 Serialization is a joint collaboration between Acsis Inc., a supply-chain visibility and traceability data collection company; Cognex Corp., a developer of machine vision sensors and systems; Nosco, a producer of pharmaceutical printed packaging; and Omega Design Corp., a machinery and package solution provider. The alliance seeks to help manufacturers, wholesale distributors, and contract producers within the pharmaceutical and bio-tech industries implement product serialization and visibility throughout the supply chain to ensure patient safety and prevent counterfeiting. The collaborative mission is to help organizations reach compliance and avoid the common pitfalls that can occur during implementation. The participating partners have a deep understanding of what is needed to be successful and support GS1 standards which ensure global traceability and visibility throughout the supply chain.
Panelists for the Webcast include:
Gregg Metcalf, Nosco
John DiPalo, Acsis Inc.
Lee Brown, Omega Design Corp.
Andrew Pietrangelo, Cognex Corp.
The team was joined by Bob Celeste, Director at GS1 Healthcare U.S.
The event is sponsored by: 
Free WEBCAST: Package Integrity: A Look at False Alarms
On Demand Webcast
Duration: 60 minutes
Registration: Click here
People often mistake visual imperfections in films as a dangerous breech of integrity. Often these anomalies are parts of the process and the parent material and have no damaging effect on fit, form, or function. In this webinar, we will provide a means to understand what gels are, how they are formed, and how to identify them. Secondly, we will address pinholes in foil to clarify what effect these pinholes have (or don’t have) on package integrity and barrier. Lastly, we will describe the existing ASTM integrity testing standards and the newest working documents on dye penetration integrity testing. These new documents will provide simple alternatives for testing integrity in non-porous and opaque materials and pouches and expand the techniques that can be used with porous packaging.
Our expert speakers from the Technical Group of the Flexible Packaging Association’s (FPA) Sterilization Packaging Manufacturers Council include: Ferdos Siadat, Quality Director, Amcor Flexibles; Geoff Pavey, Senior Principal Engineer, Oliver-Tolas Healthcare Packaging; Dhuanne Dodrill, President, Rollprint Packaging Products Inc. Our moderator is Marie Tkacik, Director of Product Development and Optimization, Beacon Converters.
The event is sponsored by SPMC member companies Oliver-Tolas Healthcare Packaging, Rollprint Packaging Products Inc., and Technipaq Inc. We thank them for their generous support.
Also in our archives:
Free WEBCAST: Establishing a State of Readiness - Mass Serialization as a Business Strategy
On Demand Webcast
Duration: 60 minutes
Registration: Click here
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| EXPERT SPEAKER: Joseph Ringwood, COO, Systech International |
Pharmaceutical & Medical Packaging News editor, Daphne Allen, and Joseph Ringwood, COO, Systech International, take an in-depth look at the global serialization landscape. In the upcoming webinar, Allen and Ringwood offer a strategic view of what manufacturers should consider when selecting a serialization approach. Additionally, the webinar will include real-world examples from industry thought leaders AstraZeneca and LifeScan to illustrate the business benefits of implementing a configurable and flexible serialization solution. During this webinar, attendees will learn about the following:
• Global pharmaceutical serialization snapshot
• Best practices to implement a global serialization approach
• Examples of how leading pharmaceutical manufacturers,
AstraZeneca and LifeScan, leveraged a configurable and
expandable solution to address serialization
• Lessons learned in mitigating risk in deploying serialization
"Early experimentation was really critical. It has enabled risk mitigation and helped us establish a state of readiness for whatever market requirements emerge."
– Christoph Krähenbühl, AstraZeneca
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"Serialization gives us extra visibility and granularity. Cartons have unique identifiers, and we know what units are on pallets. We can identify what customer is responsible for diversion."
– Stacey Brown, LifeScan
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Systech International has over 150 lines serialized and is involved in 90% of all serialization deployments. They have over 25 years experience in packaging operations and work with 19 out of the top 20 pharmaceutical manufacturers worldwide.
UPDATE: Brazil Law 11.903 - An "Emerging" Regulation for Traceability & Serialization
On Demand Webcast
Duration: 60 minutes
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| Expert speaker: Peter Schmitt, Founder and Owner, Montesino Group Peter Schmitt founded Montesino Associates in July of 1996 to provide a full range of marketing services for companies in the plastics and packaging industries in the Americas. His fluency in Spanish and extensive experience in Latin America has secured Montesino excellent credibility in the Latin American marketplace. Mr. Schmitt began his career in the early 1980s selling various types of polymeric raw materials (film, sheet, and synthetic resin) to the medical, pharmaceutical, and electronics industries in Puerto Rico and throughout the Caribbean. The company he helped build was acquired by a division of General Electric (Polymerland), and his geographic responsibilities expanded to include Mexico and Central America. Mr. Schmitt was previously Director of Marketing for American Mirrex, one of the largest producers of PVC film to the pharmaceutical and medical device industries in North America. |
Military commanders are all too familiar with the phrase (and the reality) of "the fog of war." As new regulations are promulgated and implemented, pharmaceutical packaging professionals are experiencing their own version of the phenomena: "the fog of emerging regulations." And, like military commanders, pharmaceutical executives need to make critical decisions even when all the details cannot yet be clearly seen. And yes, the devil is indeed in those details!
Brazil's Law 11.093, implementing a national serialization system for medicines, put this large emerging market at the forefront of three difficult and complex issues in pharmaceutical packaging: authentication, traceability, and serialization. The law and the original ANVISA guidelines detailed a program of serialized code in 2D data matrix format on a security label printed by the national mint that was to be implemented on a very tight timeline - initial roll out for June of 2010. Subsequent ANVISA announcements have delayed the timeline.
What is not clear to many is how to proceed today. The temptation to delay critical decisions grows each time ANVISA announces a timeline change. Indeed, the delays have led some to speculate that, like the FDA, perhaps ANVISA and Brazil will simply shelve the regulation or seriously weaken the traceability/serialization portions. But delaying preparation may not be prudent and instead could weaken a company’s competitive edge.
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| Moderated by Daphne Allen, editor of Pharmaceutical & Medical Packaging News |
Our webcast will provide the latest information on Brazil's Law 11.903 and ANVISA's guidance on compliance with the law. Specifically, the webinar presents pros and cons of developing an action plan now versus delaying major decisions. The webinar will examine similarities and difference between Brazil/ANVISA on authentication/serialization/traceability and the US/FDA or Europe/EMEA.
For those without an in depth understanding of the situation, the webinar will also include an overview of the law, its implications for companies manufacturing in Brazil and exporting to Brazil, the current status of the regulation, and expected outcomes. Also reviewed will be the role of the Casa do Moeda de Brasil (CMB; the Brazilian Mint), the use of the "security label," latest information on tamper-evident labels, data collection and transmission, and an overview of possible strategies.
REGISTER NOW TO LEARN MORE ABOUT BRAZIL'S LAW!
Now in our Archives: "Ensuring Sterile Barrier System Success"
On Demand Webcast
Duration: 60 minutes
While material selection and process control are critical to sterile barrier system success, so is user friendliness. Sterile medical packaging engineers need to develop systems that ease package opening and aseptic product presentation to avoid frustration in the end-use environment. In this exclusive Webcast, packaging technology suppliers will discuss their solutions for easing package opening as well as product identification and accessibility.
Register Now!
Speakers:
Alison Tyler
Technical Director
Beacon Converters Inc.
Alison Tyler is the Technical Director at Beacon Converters Inc. of Saddle Brook, NJ. Tyler has held previous positions in Marketing, Sales, Manufacturing, and R&D at Alcoa, DuPont, and DuPont-Merck Pharmaceuticals. Beacon Converters Inc. is a manufacturer of sterilization packaging for the medical and healthcare markets and was recently named as a top 500 Woman-Owned business in the United States. Tyler holds Bachelor Degrees of Science in both Biotechnology and Packaging Science in addition to a Masters Degree of Science in Packaging Science from Rochester Institute of Technology where she currently is an Adjunct Professor in the School of Packaging Science. She has been a member of the RIT Packaging Science Industrial Advisory Board since 2002 and currently serves as Co-Chair of the IOPP Medical Device Packaging Technical Committee.
Ed Wood
Director of Sales, Medical-Consumer-Industrial Div.
Multivac Inc.
Ed Wood, Director of Sales, Medical-Consumer-Industrial Div., Multivac Inc., has more than 16 years of senior management experience in the capital equipment industry. In leadership positions at two of the world’s largest packaging companies, he was instrumental in driving innovation and product development for major corporate clients in North America and Europe. Wood joined packaging leader Multivac Inc. in early 2007. As head of the company’s Medical-Consumer-Industrial division, his expertise is invaluable in delivering cutting-edge solutions in packaging and automation to medical manufacturers throughout the United States.
Kevin Zacharias
Engineering Program Manager
Oliver-Tolas Healthcare Packaging
Kevin Zacharias, Engineering Program Manager, manages Oliver-Tolas Healthcare Packaging’s OnSite package engineering services; he is also responsible for project management of new product development. His areas of expertise include medical package design and validation, process validation, simulated distribution testing, in-line printing systems for TFFS machines, ISO 11607 compliance, and cost savings analysis. Before joining Oliver-Tolas, Zacharias worked as Manager of Packaging Development at Baxter Healthcare and as Packaging Engineer at Boehringer Mannheim (Roche) Diagnostics. Zacharias holds a BS, packaging, and an MBA; he is a member of the Institute of Packaging Professionals.
Jason Crosby
Medical Business Manager
Plastic Ingenuity
Jason Crosby is the Medical Business Manager for Plastic Ingenuity Inc., located in Cross Plains, WI. Plastic Ingenuity, a custom thermoforming manufacturer, has formed its reputation in the industry by providing innovative packaging solutions, being customer focused and flexible. Crosby is responsible for all facets of Plastic Ingenuity’s medical packaging business, dealing daily with operations, business development, package engineering, and validation. He has a bachelor’s degree from the University of Wisconsin-Whitewater and an MBA from the University of Wisconsin. He has 13 years of thermoforming industry experience with Plastic Ingenuity. He is a member of the Society of Plastic Engineers and Institute of Packaging Professionals. Crosby has presented nationally on various topics related to medical packaging and thermoforming.
Sponsored by:
Beacon Converters Inc.
Multivac Inc.
OIiver-Tolas Healthcare Packaging
Plastic Ingenuity
From 2009:
Sustainability 102: Packaging Line Efficiency
Packaging operations for pharmaceutical and medical device products have long required robust, dependable machinery. In today’s production environment, however, companies are also looking into lean manufacturing and sustainability principles in order to improve their bottom lines and their environmental footprints. Increasing packaging line efficiency while reducing waste has therefore become just as critical.
In this Webcast, learn how your company can improve the efficiency of its packaging lines, reduce material and energy use, and increase overall equipment effectiveness.
"Sustainability 101: Beyond Recycling: Sustainability in a Material World"
This exclusive Webcast examined the challenges and opportunities faced by pharmaceutical and medical device companies in their efforts for sustainability from a material standpoint. Speakers touched upon topics such as reduction in overall material use, switches to “greener” materials, new technologies to improve efficiencies from design phase to commercial manufacturing, application of Quality by Design principles to packaging, and more.
And from 2008: Reducing Risk through Packaging
Part 1: Understanding the Nuances of ISO 11607
Members of the Sterilization Packaging Manufacturers Council discuss ISO 11607, Packaging for Terminally Sterilized Medical Devices. Split into two parts, the 2006 revision outlines requirements and responsibilities for designing sterile barrier systems and packaging systems and validating forming, sealing, and assembly processes.
Part 2: Developing Child-Resistant, Senior-Friendly Compliance Packaging
In this exclusive Webcast, speakers will offer their insights on designing and manufacturing compliance packaging that meets Consumer Product Safety Commission rules for child resistance, eases use by senior adults, and facilitates cost-efficient production. Hear from technology developers as well as automation experts on one of the most challenging aspects of pharmaceutical packaging!
Part 3: Applying RFID on the Healthcare Product Packaging Line
In this exclusive Webcast, speakers will discuss the potential role RFID can play in healthcare product identification and the technology needed to apply tags on the packaging line.
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