SPOT Radio

Reviewing the IQ, OQ, PQ process for medical device packaging compliance (Part 1)

November 02, 2020 Charlie Webb, Elon Golbaum Season 2 Episode 13
SPOT Radio
Reviewing the IQ, OQ, PQ process for medical device packaging compliance (Part 1)
Chapters
SPOT Radio
Reviewing the IQ, OQ, PQ process for medical device packaging compliance (Part 1)
Nov 02, 2020 Season 2 Episode 13
Charlie Webb, Elon Golbaum

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]

Show Notes

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]