SPOT Radio

On this episode of SPOT radio, Charlie Webb speaks with Elon Goldbaum from Network partners about the IQ, OQ, PQ process for medical device packaging validation. Does you packaging validation plan meet the requirements for ISO-11607-2019? Listen in on the edifying discussion for a solid overview of the IQ, OQ, PQ process to evaluate possible shortcomings within your medical device packaging plan.

Guest Description:
As Sr. Director of Client Solutions, Elon (Lon) Goldbaum brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality, CAPA systems and implementation of UDI requirements for Class II products. Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling, and the Apprentice program. He also managed part of a 483, and 90 CAPAs, while rebuilding the CAPA system.

Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences, and Danaher with a wide range of responsibilities, covering everything from implementing and managing packaging and labeling processes to sterilization requalification and rebuilding a CAPA system. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.

Elon Golbaum

Contact:
Website: http://www.networkpartners.com/
e-mail: [email protected]

On this episode of SPOT radio, Charlie Webb speaks with Elon Goldbaum from Network partners about the IQ, OQ, PQ process for medical device packaging validation. Does you packaging validation plan meet the requirements for ISO-11607-2019? Listen in on the edifying discussion for a solid overview of the IQ, OQ, PQ process to evaluate possible shortcomings within your medical device packaging plan.

Guest Description:

As Sr. Director of Client Solutions, Elon (Lon) Goldbaum brings over 20 years of experience in the medical device field specializing in packaging, labeling, quality, CAPA systems and implementation of UDI requirements for Class II products. Lon’s multifaceted background provides support and leadership to Network Partners’ packaging consulting, quality assurance, labeling, and the Apprentice program. He also managed part of a 483, and 90 CAPAs, while rebuilding the CAPA system.

Prior to joining Network Partners, Lon held various roles with Baxter Healthcare, Edwards Lifesciences, and Danaher with a wide range of responsibilities, covering everything from implementing and managing packaging and labeling processes to sterilization requalification and rebuilding a CAPA system. Lon earned his Bachelor of Science degree in Packaging from Michigan State University.

Elon Golbaum

Contact:

Website: http://www.networkpartners.com/

e-mail: [email protected]

In this episode of SPOT radio, Charlie Webb speaks with Laura Palker about the future of tradeshows and Expos post-COVID. When will we come together again in close proximity to each other, or will human distancing be a constant to better manage the risk of infectious Disease?  The tradeshow and expo industry is developing solutions that will make venues safer and will also develop virtual meetups as a stopgap as the pandemic risk slowly wanes.

Guest Description:

Laura Palker is an accomplished business executive with more than 25 years of experience in the Trade Show Sales and Marketing industry. She is the founder and managing director of Trade Show Solution Center/Trade Show Studio and the Solution Center Network.

Palker has developed a distinguished career working for some of the region’s top companies in the trade show industry where she was able to hone her marketing, logistics, and analytical acumen. Some of the firms that benefitted from her efforts include Exhibit Corporation of America, Exhibit Graphics, and Display Presentations.

In 2002, she branched out on her own with a vision of building a company that did more than simply sell trade show displays – one that supported the entire sales cycle with tools that worked in tandem to grow her clients’ business. That resulted in the founding of Trade Show Solution Center, a full-service agency that offers sales and lead generation tools, marketing collateral, corporate communications, trade show displays and management, and promotional items – all with an eye to presenting a clear, consistent, and compelling message that drives sales and effectively builds your brand.

Palker’s management style emphasizes strong communication, strategic planning, and internal controls to build relationships, revenues, and profits. And, with a reputation for being able to provide creative solutions for even the most complex problems, coupled with her commitment to exceptional customer service, Palker has amassed a loyal following of satisfied customers.

Giving back to the community has always been a priority to Palker as evidenced by her involvement with a variety of philanthropic and professional organizations.  Palker serves as President of the Moxxie Mentoring Foundation.  She proudly supports her husband as First Lady of the Global Board of Directors for the Institute of Management Accountants.  Palker sits on the EAC Network Board and served as former Marketing Chair and the 2014 EAC Spring Luncheon Chair.  She served on the EAC Spring Luncheon Committee in 2010, 2011, and 2012 and the EAC Golf Committee in 2011.  Finishing her term on the Board of Directors of the Executive Women’s Golf Association, Long Island, NY Chapter as the Sponsorship Chair and former Communications Chair; Palker is now co-site director for LPGA Girls Golf in Long Island.

Leading the way in an annual fundraiser for the American Cancer Society, she chaired the Island Hills Golf Club Babe Zaharias Tournament in 2008 and 2009 and served on the Executive Committee in 2011. Previous to that she served on the Board of the Foundation Fighting Blindness and worked with the Long Island Foundation for Hospice Care and Research where she lobbied in both Albany and Washington D.C. to help build awareness and support for hospice as an alternative to traditional cancer treatment in the late 1980s. Palker continues to offer seminars and webinars on profitable trade show exhibiting and smart selling. She is a regular columnist in Golfing Magazine, Networking Magazine, and hosted the FIOS1 My LI Show “Golfing on Long Island in 2011.  Laura Palker and her husband Marc P. Palker reside in South Huntington, NY.

Laura Palker

Contact:

Website: www.tssolutioncenter.com 

E-mail: [email protected]

In this episode of SPOT radio, Charlie Webb speaks with Ryan Erickson Vice President of Packaging Compliance labs about the value of outsourcing medical device packaging validation, engineering, and testing lab services. As we develop more complicated medical devices with embedded drugs, packaging systems will continue to become more complex.  SME's can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019.

Guest Description:

Ryan Erickson is a co-founder and Vice President of Packaging Compliance labs; he serves as the technical expert on the team, guides trainings, and runs lean events. Erickson formed PCL with partner Matthew Lapham with the mission to help medical device and pharma clients speed their products to market by breaking down the barriers that relate to packaging. 

Ryan has 12 years’ experience in medical device packaging engineering, beginning as a Packaging Engineer at Cardinal Health in Chicago. At Cardinal Health, Ryan served as a packaging engineer as he developed his skills in packaging validation and testing. Upon returning to his hometown of Grand Rapids, Erickson became the Packaging Engineering Manager for Vention Medical, a large contract manufacturer.

Ryan Erickson

Contact:

Website: https://pkgcompliance.com

e-mail: [email protected]

In this episode of SPOT radio, Charlie Webb speaks with Lisa Wassberg general manager of Van der Stahl Scientific about the importance of proper machine care. Siloed quality departments often seem unaware of maintenance issues that could risk their sterile packaging program. Listen in and hear the perspective of a medical device packaging machine provider regarding the proper care of the critical equipment.

Guest Description:

Lisa Wassberg is the General manager of Van der Stahl Scientific, she has worked as the general manager of an industrial caster company overseeing the process from development to distribution. She worked as a marketing manager from one of the nation's oldest custom metal fabrication companies developing key national accounts in a highly competitive industry. Lisa is certified as a Kaizen facilitator and co-manages Van der Stahl Scientific's busy ISO-17025 calibration and testing Laboratory.   

Lisa Wassberg

Linkedin:

https://www.linkedin.com/in/lisa-wassberg-webb-07769bb/

In this episode of SPOT radio we ask the question, how are medical device manufacturing and packaging engineers managing with the new connection tools such as videoconferencing during this pandemic event? The COVID event continues to make collaboration difficult as packaging validation requires many hands-on steps and connections. In this episode we speak with medical device packaging engineer Swandand Kuuawar from Abbott to learn about his workflow during the challenging COVID event.

Guest Description:

Swanand Kullarwar is a packaging engineer at Abbott and was previously a packaging engineer at Zimmer Biomet. Sawnand holds a master's in packaging science degree from RIT and a bachelors degree in printing engineering from India. Swanand is currently working on his CPP (certified packaging professional) certification. 

Swanand Kullarwar

Linkedin:

https://www.linkedin.com/in/swanand-kullarwar-45540716/?msgControlName=reply_to_sender&msgConversationId=6636453303867756544&msgOverlay=true

On this episode of SPOT radio, we discuss protecting our brands and products from counterfeiters with our guest Robert Sherwood from Veritrace. Worldwide sales of counterfeit medications could top $75 billion this year. This is a 90% rise in five years according to an estimate published by the Center for Medicine in the Public Interest of the United States of America. This influx of counterfeit medicines into the marketplace poses huge risks to consumers. Robert speaks to solutions that Veritrace has created to combat this threat.

Guest Description:

Robert Sherwood, CPP, is a security print and software technology specialist with 25 years of Brand protection experience.  He designs security solutions to protect IP, products, revenue, customers, and to reduce liability.  He applies a total approach to brand protection solutions by analyzing counterfeiting, diversion, supply chain security, packaging, and stakeholder concerns.

His packaging and labeling expertise includes security design, anti-counterfeit print technologies, substrates, adhesives, specialty converting, and authentication/track & trace software systems. 

Robert holds certification as an ASIS Certified Protection Professional. He is a past chairman and current board member of NASPO International and contributed to the writing and publishing of the 2015 ANSI/NASPO International Security Management Standard.VeriTrace Inc.

Robert Sherwood

513.673.1576
[email protected]

Website
www.veritrace.com

On this episode of SPOT radio, we discuss automated handwashing systems with our guest Paul Barnhill from Meritech. Mr. Barnhill speaks on best practices in hand hygiene and how automated technologies can greatly improve Hand Washing outcomes. Medical device manufacturing will benefit from these automated technologies as they can now better control bioburden in the cleanroom.

Guest Description:

Paul Barnhill is Chief Technology Officer and Head Engineer at Meritech, the leader in automated employee hygiene. He has over 28 years of experience working with professionals in food manufacturing, healthcare, and food service to understand the challenges they face when creating hygiene programs and how to overcome these obstacles through education and automated technologies. 

Mr. Barnhill often speaks on best practices in hand hygiene, footwear sanitation, and the science behind pathogen removal. Helping food processing and packaging facilities produce safe and healthy products through hygiene excellence is a passion for him. Prior to joining Meritech, Mr. Barnhill worked at Medtronic, Inc. a leader in cardiovascular equipment and implantable devices, in their Hemostasis division as a Mechanical Designer within the R&D department.

Mr. Barnhill earned his accreditation degree from the A.I.D.D. (American Institute for Design & Drafting). When he's not inventing a new method for guaranteeing effective hygiene, you can find Mr. Barnhill spending time with his loving wife Ann of 26 years, son Josh, daughter-in-law-to-be Emily, and dog Beau at his home in Aurora, Colorado.

Website:
https://www.meritech.com/

Phone:
+1 800-932-7707

On this episode of SPOT radio, we speak once again with medical device packaging influencers Rod Patch and Jennifer Benolken about the progress of the "Kilmer innovations in packaging" group. This group hopes to imagine best practices in sterile packaging and will pose questions to colleagues that will spark innovations that will shape the future of medical device sterility and delivery.

Guest  Description:

Rod Patch is Senior Director, Package Engineering & Product Labeling for Johnson & Johnson Vision.  In his role, Rod serves the needs of J&J’s Vision Franchise with packaging strategies, innovation programs, talent, regulations and supply chain improvements. Rod is responsible for both J&J Vision Care and J&J Surgical Vision within the J&J Vision Franchise.     

Rod is an accomplished leader with a broad base of experience in sterile barrier package design and labeling systems. Rod has supported packaging his entire career working in operations, supply chain, and R&D functions where he has led and managed teams supporting the package design, package process, package delivery as well as product label designs.    

Rod is an industry-recognized expert in sterile barrier packaging. Rod is J&J’s primary delegate to ISO/TC198 WG7 Packaging and is an approved consensus U.S. Expert at international meetings. Rod is also J&J’s primary voting member for ASTM F02 and D10, supporting packaging standards.

Our 2nd guest:

Jennifer Benolken, CPPL, is the Western Region Medical Device and Pharmaceutical Manufacturer and Regulatory Specialist with DuPont Tyvek® Medical Packaging; she works with downstream customers at medical device and pharmaceutical organizations, providing education and answering questions about Tyvek® packaging and sterilization. Jen has worked in the medical device community since 1991 in a variety of packaging related roles - packaging/labeling/sterilization engineer (in both operations and R&D roles), flexible packaging sales representative, and manager of packaging engineering and labeling groups.

While Jen earned her undergraduate degree in Manufacturing Systems Engineering at Kettering University (Flint, MI), she came to love packaging through her collegiate co-operative work experience at CPI/Guidant. Jen furthered her education by obtaining a Master of International Management degree from St. Thomas University (St. Paul, MN). She is currently the sub-committee chairperson for ASTM F02.50, Package Design and Development, as well as co-chair for AAMI’s ST/WG 7, Packaging Working Group, the US’s mirror group to ISO TC198/WG7. 

Jen is also an active member of the Institute of Packaging Professionals (IoPP) where she attained her lifetime Certified Packaging Professional (CPPL) certification in 2012. As part of IoPP, Jennifer has recently been elected to the Board of Directors and is also Vice-Chair on its Medical Device Packaging Technical Committee (MDPTC) board.

Kilmer Innovation in Packaging

https://www.linkedin.com/groups/12301596/?msgConversationId=6592084813891596289&msgOverlay=true

Rod Patch

https://www.linkedin.com/in/rod-patch-756227a/?msgConversationId=6592084813891596289&msgOverlay=true

Jennifer Benolken, CPPL

https://www.linkedin.com/in/jbenolken/?msgConversationId=

This episode our host Charlie Webb speaks with Larry Nichols From Next Thermal on the process of Integrating heating and temperature sensing systems to medical devices.

Guest  Description:

Larry Nichols is a Technical Manager with Next Thermal, he is an MBA and with 24 years of industrial sales experience. Larry shares his skills with his students as an adjunct professor at Baker College.

(269) 964-0271

www.nexthermal.com