Webinars

Don't miss PMP News's exclusive Webcast:

UPDATE: Brazil Law 11.903 - An "Emerging" Regulation for Traceability & Serialization

Date: September 16, 2010
Time: 2:00 PM ET | 11:00 AM PT
Duration: 1 Hour

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.

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.

Now in our Archives: "Ensuring Sterile Barrier System Success"

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.

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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