We visit with Greg Jones from SGS North America and gain insight into the ISO 13485 certification process from a seasoned auditor. Start-ups or established medical device manufacturers can benefit from this discussion as we speak about potential pitfalls that could jeopardize accreditation. 

Guest  Description:

Greg Jones is the Technical Director at SGS in North America. In that capacity, Greg is responsible for all technical and operational aspects of medical device certification including ISO 13485, MDSAP, MDR and IVDR. Greg brings over 15 years of experience in Medical Device Certification and prior to that spent over 10 years in Research & Development as a Process Engineer with a leading Medical Device manufacturer. He is a certified lead auditor for ISO 9001 and ISO 13485. Greg earned his Bachelors at Belmont University.

201.296.5353

www.sgs.com

Email [email protected]

Listen in as we speak with the founder and president of AWS Bio-Pharma Technologies. Bruce speaks on how the process of a modular cleanroom is specked out and delivered. Bruce has great insight into the process of controlled environments from his 40 years of experience in facilities and process engineering, and management.

Guest  Description:

Bruce Anthenat earned his BS degree from the College of Engineering and Technology of Southern Illinois University.  He has also obtained the status of Certified Plant Engineer as recognized by the Association of Facilities Engineers (AFE). He is Past-President of AFE Chapter 126 and has made several presentations on a variety of topics to various professional organizations including AFE, ISPE, and the PDA.

Bruce has over 40 years of experience in facilities and process engineering, and management with the last 30+ years in pharmaceutical engineering and manufacturing management for a variety of well-known injectable drug manufacturers.  In February of 2000, he received the Engineer of the Year award from his peers in AFE Chapter 126. He has been a past member of the Board of Directors for the International Society of Lyophilization, a member of PDA Glass Handling Task Force, project manager and lead technical authority for a number of new and renovated pharmaceutical manufacturing facilities.

He is the primary patent holder of US Patent# 831667 [a method and apparatus for high-velocity electromagnetic sealing of containers (primarily for Parenteral vials and cartridges].  Mr. Anthenat entered into the entrepreneurial world by founding AWS Bio-Pharma Technologies in 2005, where he continues to provide leadership to this growing company.  He is a proven leader, with a keen sense of observation and analytical skills, which provides him with the knowledge to administer and inspire others while developing a genuine understanding of their point of view. His vision includes helping others achieve very memorable accomplishments in his related areas of expertise.

877-297-7763

https://www.awsbiopharma.com

On this 2 part Podcast, we speak with Joe Campbell of Universal Robots about how collaborative Robots can make a more efficient workflow on the packaging line in the cleanroom. As throughput demand for medical devices continues to surge medical device packaging engineers will look at smaller, easy to integrate Robots as a scalable cost-effective solution.   

Guest  Description:

Joe Campbell is the head of strategic marketing and applications development for Universal Robots North America, where he is leveraging his 35+ years’ experience in the robotics and factory automation industry.  Prior to joining Universal, Joe was vice president sales & marketing for Swiss-based gantry robot and track manufacturer Gudel.  Previous assignments include executive roles in sales, marketing, operations and customer service with industry leaders including ABB, KUKA, AMT, and Adept.  Joe has also consulted to the industry on strategy, marketing, M&A and product development.

Joe is a graduate of the University of Cincinnati. He is a regular speaker and lecturer at trade shows, industry events, and manufacturing symposiums, presenting the technology and economic benefits of robots and factory automation.  Joe and his family live in Birmingham, MI.

https://www.universal-robots.com

On this 2 part Podcast, we speak with Joe Campbell of Universal Robots about how collaborative Robots can make a more efficient workflow on the packaging line in the cleanroom. As throughput demand for medical devices continues to surge medical device packaging engineers will look at smaller, easy to integrate Robots as a scalable cost-effective solution.   

Guest  Description:

Joe Campbell is the head of strategic marketing and applications development for Universal Robots North America, where he is leveraging his 35+ years’ experience in the robotics and factory automation industry.  Prior to joining Universal, Joe was vice president sales & marketing for Swiss-based gantry robot and track manufacturer Gudel.  Previous assignments include executive roles in sales, marketing, operations and customer service with industry leaders including ABB, KUKA, AMT, and Adept.  Joe has also consulted to the industry on strategy, marketing, M&A and product development.

Joe is a graduate of the University of Cincinnati. He is a regular speaker and lecturer at trade shows, industry events, and manufacturing symposiums, presenting the technology and economic benefits of robots and factory automation.  Joe and his family live in Birmingham, MI.

https://www.universal-robots.com

Accurate regulatory-compliant packaging machine calibrations are the headwater to a rounded medical device packaging program. Many medical device makers are falling short with their calibration, is your company at risk. On this episode of SPOT radio our guess Cord Burnham CKF speaks to the 5 common mistakes in packaging machine calibrations.

Guest  Description:
Cord Burnham CKF Cord Burnham is the director of laboratory services for Van der Stahl Scientific's ISO-17025 accredited calibration laboratory. Cord has traveled throughout the country providing technical and calibration services to the largest and smallest medical device manufacturers. He is Six Sigma trained and a Kaizen trainer.  

www.vanderstahl.com 

Jan Gates provides valuable insight on how to conform to the latest iteration of the ISO-11607-2019. This lively discussion speaks to potential shortcomings of some device makers in terms of packaging their medical devices. If you are an ISO 13485 medical device manufacturing you will surely benefit from this important discussion.

Guest  Description:

Jan Gates has 35+ experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements; also, included are production optimization, validation, and minimal packaging for sustainability. 

She has previously worked for Bristol Myers Squib, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as an independent consultant in her company, PackWise Consulting, and with Adept Packaging as their VP of Client Solutions and Principal Packaging Engineer.

Jan works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing. 

She is also working as a US representative on various ISO TC 122 committees for packaging tests, vocabulary, labeling, and product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices); the guidance document was converted to ISO/TS 16775. She is on the IoPP (Institute of Packaging Professionals) HealthPack Advisory board, IoPP Medical Device Packaging Technical Committee and is the Southern California IoPP Co-president. 

Contact: Jan Gates 

ph-650.743.5780

packwiseconsulting.com or Adeptpackaging.com

Jan Gates provides valuable insight on how to conform to the latest iteration of the ISO-11607-2019. This lively discussion speaks to potential shortcomings of some device makers in terms of packaging their medical devices. If you are an ISO 13485 medical device manufacturing you will surely benefit from this important discussion.

Guest  Description:

Jan Gates has 35+ experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements; also, included are production optimization, validation, and minimal packaging for sustainability. 

She has previously worked for Bristol Myers Squib, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as an independent consultant in her company, PackWise Consulting, and with Adept Packaging as their VP of Client Solutions and Principal Packaging Engineer.

Jan works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing. 

She is also working as a US representative on various ISO TC 122 committees for packaging tests, vocabulary, labeling, and product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices); the guidance document was converted to ISO/TS 16775. She is on the IoPP (Institute of Packaging Professionals) HealthPack Advisory board, IoPP Medical Device Packaging Technical Committee and is the Southern California IoPP Co-president. 

Contact: Jan Gates 

ph-650.743.5780

packwiseconsulting.com or Adeptpackaging.com

David Cocke MBA, offers insight on delivering medical devices to the point of care from his 25 years of managing a contract packaging company. Charlie Webb and David speak to the challenges of medical device packaging from regulatory science, cost containment as well as managing cleanroom staff.

Guest  Description:

David Cocke David is an MBA and he has spent the past 27 years in medical device manufacturing at the executive level. Currently, David is the VP of Manufacturing at NuPak Medical an ISO 13485 certified contract manufacturer that specializes in thermoplastic injection molding, silicone molding and assembly and packaging in controlled environments.

We were interviewed on the Podcast "Beyond Clean" and spoke on the contrasting approach of medical device packaging OEM's and SPD groups. Also, Charlie gives a brief talk on the growth and challenges of the "Sterile Packaging on Track" Podcast.

Guest  Description:

Beyond Clean Podcast takes a creative look into the inner workings of the healthcare industry at the Hospital level, which is surrounded by challenges and disrupted by change. The team at Beyond Clean brings on the biggest names in surgical instrument reprocessing and provide commentary on the biggest issues facing sterile processing professionals, facilities, administrators, manufacturers, and vendors.

www.beyondclean.net

Our host Charlie Webb CPP interviews Richard Hogan of ISO budgets and learns about his 7 step approach to estimating measurement uncertainty.  Listen in on this informative conversation and gain a clearer view of this often challenging process.

Guest  Description:

Richard Hogan holds a bachelors and master’s degree in Engineering and his consultancy ISO budgets, specializes in measurement uncertainty analysis for ISO 17025 accredited laboratories. His process for estimating measurement uncertainty has helped more than 9,000 laboratories worldwide get accredited. He combines his cross-functional competencies in all phases of Metrology, including calibration, quality management, and research.    

www.isobudgets.com