# 197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-07-16
- Length: 13m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-16-197-quality-agreements-explained-how-to-protect-yourself-when-things-go-wrong
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/197---Quality-Agreements-Explained-How-to-Protect-Yourself-When-Things-Go-Wrong-e35jotb

## Summary

Subhi Saadeh, host of Let's Combinate and Quality Professional, explains the critical role of quality agreements in pharmaceutical and medical device industries, emphasizing that product owners retain ultimate accountability even when work is outsourced. She outlines five essential sections every agreement must cover: deviation handling, change control, audits, complaint handling, and documentation retention, citing FDA 21 CFR 820.50 and ICH Q10 as key regulatory drivers. Saadeh warns against vague language and misaligned expectations, using case studies of falsified test results and unauthorized process changes to illustrate the risks of inadequate oversight.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-16-197-quality-agreements-explained-how-to-protect-yourself-when-things-go-wrong#t=0) Introduction: The Importance of Quality Agreements

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

established companies

## Mentioned

- FDA (company)
- 21 CFR 820.50 (other)
- 21 CFR 806 (other)
- 21 CFR Part 4B (other)

## Related episodes from other shows

- [How to Build a QMS for a Medical Device](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device) (Global Medical Device Podcast)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)
- [Quality Myths and Lessons Learned](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned) (Global Medical Device Podcast)
- [How to Select a Contract Manufacturer](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer) (Global Medical Device Podcast)
- [Past, Present, Future State (and World) of Quality in the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry) (Global Medical Device Podcast)

## Citing this page

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