Hardware Podcasts

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

Let's Combinate · 16 Jul 2025 · 13m

What this episode covers

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.

Most relevant to

established companies

Topics

Mentioned

Companies
FDA
Also
21 CFR 820.50, 21 CFR 806, 21 CFR Part 4B

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