# 122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-02-07
- Length: 35m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-07-122-intricacies-of-joint-audits-rx360-supply-chain-security-and-networking-in-ph
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/122---Intricacies-of-Joint-Audits--Rx360--Supply-Chain-Security--and-Networking-in-PharmaMedTech-with-Jim-Fries-e2fc2ij

## Summary

Jim Fries, CEO of the nonprofit consortium Rx360, explains the mechanics and benefits of their joint audit program, which allows multiple pharmaceutical sponsors to share the cost of auditing a single supplier facility. He details how independent auditors conduct these reviews, how reports are licensed rather than shared openly, and how the model reduces the audit burden on suppliers while maintaining supply chain integrity. Fries also discusses the organization's evolution from its origins in the Hepburn contamination crisis to its current role in supply chain security, emphasizing the importance of member-driven working groups and relationship building.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-07-122-intricacies-of-joint-audits-rx360-supply-chain-security-and-networking-in-ph#t=0) Introduction: Subi Sedate and Jim Fries on Rx360
- [5:45](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-07-122-intricacies-of-joint-audits-rx360-supply-chain-security-and-networking-in-ph#t=345) The Joint Audit Model: Process, Sponsors, and Auditors
- [9:54](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-07-122-intricacies-of-joint-audits-rx360-supply-chain-security-and-networking-in-ph#t=594) Regulatory Compliance, Scoping, and Confidentiality
- [15:05](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-07-122-intricacies-of-joint-audits-rx360-supply-chain-security-and-networking-in-ph#t=905) Audit Frequency, Reevaluation, and Post-Pandemic Cadence
- [19:12](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-07-122-intricacies-of-joint-audits-rx360-supply-chain-security-and-networking-in-ph#t=1152) Licensable Audit Reports vs. Shared Reports
- [23:31](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-07-122-intricacies-of-joint-audits-rx360-supply-chain-security-and-networking-in-ph#t=1411) Industry Challenges: Supplier Burden and Education
- [27:32](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-07-122-intricacies-of-joint-audits-rx360-supply-chain-security-and-networking-in-ph#t=1652) Rx360 History, Working Groups, and Supply Chain Security
- [29:58](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-07-122-intricacies-of-joint-audits-rx360-supply-chain-security-and-networking-in-ph#t=1798) Networking, Relationship Building, and Leadership Advice

## Topics

- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

established companies

## Mentioned

- Rx360 (company)
- Hepburn (other)
- FDA (other)
- USP (other)
- ASQ (other)

## Related episodes from other shows

- [R&D RADIO: How to Audit a Co-Packer: The Food QA's Hermi Galstian Explains](https://hardwarepodcasts.com/podcast/the-startup-cpg-podcast/2026-08-17-r-d-radio-how-to-audit-a-co-packer-the-food-qas-hermi-galstian-explains) (The Startup CPG Podcast)
- [Auditing the Auditor](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor) (Global Medical Device Podcast)
- [Counterfeit Detection & Supply Chain Risks with Cofactr](https://hardwarepodcasts.com/podcast/ontrack/2024-10-31-counterfeit-detection-supply-chain-risks-with-cofactr) (OnTrack)
- [#257 Co-Man Due Diligence 101 with Riot Energy and Kelley Drye & Warren LLP](https://hardwarepodcasts.com/podcast/the-startup-cpg-podcast/2026-07-14-257-co-man-due-diligence-101-with-riot-energy-and-kelley-drye-warren-llp) (The Startup CPG Podcast)
- [Navigating the Medical Device Single Audit Program (MDSAP)](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-13-navigating-the-medical-device-single-audit-program-mdsap) (Global Medical Device Podcast)

## Citing this page

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