SPOT Radio

On this episode of SPOT radio, Charlie Webb speaks with Lindsay Lannelli a candidate connection Specialist for the Adept Group about her experience working from home. Many people turned their time at home into gains on domestic projects and they sharpened their work skills. Listen in on how Lindsay approached the shutdown era.  

Guest Descriptions:

Lindsay Iannelli is a Candidate Connection Specialist for Adept Group, where she connects the leading brands in the Life Science, Food, Beverage, and CPG industries to elite packaging talent to unlock opportunities and create solutions. The Adept Group delivers best-in-class engineering, consulting, talent, and digital solutions for the packaging world.

Website:

www.adeptpackaging.com

Phone: 610-739-7347

Email: [email protected]

Linkedin: www.linkedin.com/in/lindsay-iannelli-7a56a4b7

On this episode of SPOT radio Charlie Webb speaks with Tom Widroe from the Tom Widroe Group on the future of dispersed employees. We also chat about key motivators that will attract better employee candidates by expanding flexible work location options.      

Guest Descriptions:

Thomas Widroe is the founder and principal of The Widroe Group, since 1998, T-W-G has been helping public, private, and non-profit organizations win the war for talent. Tom Widroe's placement expertise in a host of industries including technology, healthcare, professional services, finance, manufacturing, and government agencies.

Tom worked as an operation executive at Bargain Network, a $75 million subscription-based information service with over 700 employees. Tom’s education includes two degrees from the University of California, Santa Barbara.

Contact:

Website: www.practiceinparadise.com

email: [email protected]

Phone: 805.680.7772

On this episode of SPOT radio, Charlie Webb speaks with Mark Escobedo a Senior Sales Engineer at Westpak about the process of accelerated aging. This podcast provides a solid overview from the vista of a medical device packaging testing laboratory. Westpak is an ISO 17025 Accredited Independent test laboratory. Their Laboratory covers a variety of testing processes including Environmental conditioning, Package Performance testing, as well as Accelerated and real-time aging.

Guest Descriptions:

Mark Escobedo is a Senior Sales Engineer at Westpak providing technical expertise in the medical device and pharmaceutical industries. Mark holds a degree in Package Engineering from San Jose State University.  Mark is also a member of ASTM Committees D10 and F02 where he participates in the development of standards. In addition to writing articles for industry publications, Mark has also conducted seminars on a variety of testing-related topics. His goal is to provide the guidance necessary for a successful regulatory submission as it pertains to packaging.

Contact:

Website:

www.westpak.com

email:

[email protected]

Phone:

1 (800) 830-8020 

On this episode of SPOT radio, Charlie Webb speaks with Wendy Mach with Nelson Labs about their upcoming Packaging Validation 101 Webinar. This online event will cover topics such as: determining the appropriate sample size for testing, writing the validation protocol, developing the test plan, selecting appropriate tests, family grouping and worst-case considerations, and creating the appropriate samples.

Guest Descriptions:

Wendy Mach is with Nelson labs, she has over 27 years of medical device manufacturing and laboratory experience. She is a known expert in the MedTech packaging industry, a sought-after speaker, and actively contributes to industry publications.

 In her role as Consulting Manager, Wendy works with clients to address their unique needs in order to meet the requirements for packaging validations.

Wendy is a participating member of the Technical Committee ISO/TC 198 Sterilization of Healthcare Products, the subcommittee chairperson for ASTM F02.15 Chemical / Safety Properties, and is chairperson of the Packaging & Sterile Barrier Systems Working Group for the Society for Sterilization Assurance Professionals (SfSAP). Wendy's participation on the domestic and international committees allows her to consult with clients to meet the regulatory standards of today – while preparing them to meet the demands of the future."

Event link for more information and to register: 

https://www.nelsonlabs.com/events/packaging-validation-101/ 

Contact:

Website: www.nelsonlabs.com

email: [email protected]

Phone: 1 (800) 826-2088

On this episode of SPOT radio, Charlie Webb speaks with the technical sales team at Merrill's Packaging. Dan Kelly, Andy D'Esposito CPP, and Kevin Scott provide insight on the process of custom medical thermoforming. This year Merrill's is celebrating its 60th year and is a custom thermoformer based in the California Bay Area with a second location in Costa Rica. They have a custom medical thermoforming focus plus also form food, retail, and electronic packaging. Through the years, they have become a trusted leader in thermoforming, supplying many of the world's largest medical companies.

Guest Descriptions:

Dan Kelly Soon after graduating college in the mid-'90s with a BS in Engineering, Dan moved into a project management/application's engineering role with a top packaging machinery manufacturer in Cape Cod, MA.  Soon thereafter he transitioned to a sales role and promoted their business in Europe. In the early 2000's Dan moved back to the states and has been in the custom thermoforming environment ever since.  Dan enjoys the healthcare side of packaging as it continuously evolving to better serve the patient.  In his spare time, Dan enjoys coaching youth basketball, boating, running road races, and spending time with his wife and their 2 children. [email protected] 

Andy D'Esposito CPP graduated from Cal Poly San Luis Obispo in 1981 with a degree in Marketing.  After that, he started working in the packaging industry and has been for 40 years with the last 11 years in Medical Packaging.  He is on the board for IOPP in Southern California and also on the board for the ASTM F-02 group.  Andy received his Certified Packaging Professional certificate about 10 years ago and remains active in his local chapter.  His knowledge and experience in various packaging industries allow him to offer customers and prospects a myriad of advice and assistance in their efforts to develop various types of packaging.  Having worked for companies large and small he has developed a sales style that fits any sized company.  Andy was also part owner in a medium-sized retail thermoforming company in Southern California for 10 years and fully grasps the intricacies of running a business including accounting, human relations, marketing, production, quality control, and inventory management.  In his spare time, Andy enjoys boating, skiing, backpacking, golf, travel, and spending time with his family. [email protected] 

Kevin Scott has been in custom thermoforming for close to 15 years with a short stint in pharmaceutical packaging. For the past ten years, his primary focus has been on medical & pharma packaging. Since graduating from NC State with an accounting degree in 2000, he has worked in plastics, starting with an injection molder in the accounting department and finding his calling in sales. When he isn't traveling for work or pleasure, he is an avid runner and enjoys professional boxing in his free time. He lives in Raleigh, NC, with his family. [email protected] 

Contact:

Website: merrills.com

email: [email protected]

Phone: 800-284-5910

On this episode of SPOT radio, Charlie Webb speaks with Curtis Gippe the director of the Life Science practice at Adept Packaging. In this discussion, we talk about the end-to-end challenges of pre-filled syringe packaging development.  

Guest Description:

Curtis Gippe is the director of the Life Science practice at Adept Packaging, which delivers best-in-class engineering, consulting, talent, and digital solutions for the packaging world. He is a driven, highly accomplished Packaging Engineer with expertise in packaging design and development and more than 15 years' experience in pharmaceutical (over the counter and prescription), medical device (auto-injectors, pre-filled syringes, and other injectables), and consumer products (Oral Care, Beauty, Intimate health, and Women's healthcare packaging goods). He is a strong leader and accustomed to working in highly regulated industries. His other specialties include working with IM, IBM, EBM processes, mold qualifications, thermoforming, new packaging development, and platform development. 

- ASTM committee member for F02, D10, & D37
- Lean six sigma certified 
- Hazmat and Dangerous Goods Certified- Holds a bottle design patent for a class 2 medical device

Curtis Gippe

Contact:

Website: www.adeptpackaging.com

Contact: Curtis Gippe
Director of Life Sciences
Adept Group
c: +1.585.703.4022
o: +1.484.373.2504
www.adeptpackaging.com

On this episode of SPOT radio, Charlie Webb speaks with Don Alip about "Sterile Packaging Day"  Listen and learn about this exciting day of awareness that takes place on March 10th, 2021.  Please follow the link at the bottom of this Podcast description to view valuable infographics that highlight this event. Don also shares ways that you and/or your company can participate.

Guest Description:

Don Alip is currently Director of Product Excellence, at Amcor, and is responsible for driving the product growth strategy and leading Amcor’s product management and field service teams. Since 2019, Don has served as Marketing Committee Chairman for the Sterilization Packaging Manufacturer’s Council (SPMC), an industry organization dedicated to developing consensus on test methodology among industry-leading sterilization packaging manufacturers and publishing guidance documents for healthcare packaging validations.

Under Don’s leadership, the SPMC will be sponsoring the inaugural Sterile Packaging Day event on March 10, 2021, to create awareness of sterile packaging’s vital role in healthcare and keeping patients safe.

Don Alip

Contact:

Website: https://www.sterilizationpackaging.org/sterile-packaging-day

Contact: https://www.sterilizationpackaging.org/members/amcor.

Podcast Episode Description:

On this episode of SPOT radio, Charlie Webb speaks with Ryan Erickson and Ryan Ott of Packaging Compliance labs about the needed step to conform to the UDI (Unique Device Identification) printing requirements. Also discover how SMEs can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019 and the UDI (unique device identifier) printing directive.

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.

Contact:

Website: https://pkgcompliance.com

e-mail: [email protected]

Ryan Ott is the Director of Quality and Principal Packaging Engineer at Packaging Compliance Labs; he is PCL’s resource for all things quality related including, but not limited to, executing supplier agreements, answering questions about test standards, and scheduling audits.

Ott earned a degree in Packaging at Michigan State University and began his career in Packaging at Vention Medical. In 2016, Ott joined Packaging Compliance Labs as a Senior Packaging Engineer.

Website: https://pkgcompliance.com

e-mail: [email protected]

UDI Links for reference:
Here’s the Primary GS1 site (You can go to the U.S. or Global sites from here):

 https://www.gs1.org/
Download the GS1 General Specifications Guide here:

https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specific…
FDA website for UDI:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-…

Podcast Episode Description:

On this episode of SPOT radio, Charlie Webb speaks with Ryan Erickson and Ryan Ott of Packaging Compliance labs about the needed step to conform to the UDI (Unique Device Identification) printing requirements. Also discover how SMEs can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019 and the UDI (unique device identifier) printing directive.

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.

Contact:

Website: https://pkgcompliance.com

e-mail: [email protected]

Ryan Ott is the Director of Quality and Principal Packaging Engineer at Packaging Compliance Labs; he is PCL’s resource for all things quality related including, but not limited to, executing supplier agreements, answering questions about test standards, and scheduling audits.

Ott earned a degree in Packaging at Michigan State University and began his career in Packaging at Vention Medical. In 2016, Ott joined Packaging Compliance Labs as a Senior Packaging Engineer.

Website: https://pkgcompliance.com

e-mail: [email protected]

UDI Links for reference:
Here’s the Primary GS1 site (You can go to the U.S. or Global sites from here):

 https://www.gs1.org/
Download the GS1 General Specifications Guide here:

https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specific…
FDA website for UDI:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-…

On this episode of SPOT radio, Charlie Webb talks about expanding the show to cover topics deeper within medical device manufacturing as well as discussions surrounding challenges in the sterile processing departments at hospitals and clinics. As SPOT radio podcast expands the scope of the show packaging engineers will gain valuable insight into all aspects that affect their mission to deliver medical devices safe and sterile to the point of care. Welcome to season three.

Host Description:

Charlie Webb is the founder and President of Van der Stahl Scientific; He also hosts SPOT Radio (sterile packaging on track) www.spotradiopodcast.com 

Charlie earn his BS degree in Management at the University of Redlands and completed the medical device development program at the Andersen graduate school of management at UCLA. Charlie is a “lifetime” certified packaging professional “CPPL” certified through the institute of packaging professionals as well as a “Six Sigma Master Black Belt”. As a member of a scientific review board, he co-developed micro-surgical devices that broke away from the conservative innovation models. Charlie has been in sterile device packaging for 25 years and has been involved in numerous FDA and ISO audits as a regulatory advisor.

He is also a certified internal auditor and is the Quality Manager for Van der Stähl Scientific’s demanding ISO/IEC 17025 accreditation. Charlie is a member of the IOPP Medical Device Packaging Technical Committee, and the ASTM F02 technical committee and has multiple granted and pending patents on medical device packaging machinery and pouch testing systems.

His current patent-pending technologies include a medical device tray sealer that will integrate pouch testing within the packaging machine to provide 100% real-time seal testing. Also, in development is the HTIP system (human tissue isolation pouch) this disposable system is designed to help avoid packaging machine contamination. The seal-through HTIP system isolates the donor tissue during the packaging process to help thwart cross-contamination between donor events. This system will help prevent machine contamination and increases packaging machine component life cycles, saving money while managing infection risks to donor recipients.

His company was also recently awarded a federal contract as a medical device packaging machine provider for the VA Hospital group and his laboratory client list includes NASA and the CDC (center for disease control). He continues to grow his company’s new product development program with the aim of reaching more users of their equipment in order to better manage healthcare packaging failures.

Contact:

[email protected]