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

Let's Combinate - Drugs + Devices

In this episode of Let’s Combinate, host Subhi Saadeh breaks down the critical role of quality agreements in the pharmaceutical and medical device industries.A quality agreement is a written document that defines GxP responsibilities between parties—such as sponsors, product owners, and contract partners. It doesn’t cover business terms like payments or IP: instead, it focuses on quality responsibilities and operational accountability.

Subhi explores regulatory expectations from the FDA, ICH Q10, and ISO 13485, emphasizing that even when work is outsourced, responsibility always stays with the product owner. He outlines five key sections every quality agreement should cover:

-Deviation & Non-Conformance Handling

-Change Control

-Audits & Regulatory Inspections

-Complaint Handling & Field Actions

-Documentation & Record Retention

This episode highlights common pitfalls, vague language to avoid, and why quality agreements must be clear, specific, and actionable especially when something goes wrong.

⏱️ Timestamps

00:00 – Intro: Why Quality Agreements Matter

01:23 – What Is a Quality Agreement?

03:24 – Regulatory Expectations (FDA, ICH Q10, ISO 13485)

04:51 – FDA’s Quality Agreement Guidance Explained

06:34 – Common Pitfalls & Misunderstandings

08:00 – The 5 Critical Sections Every Agreement Needs

12:34 – Final Thoughts: Make It Real. Make It Work

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.