Hardware Podcasts

043 - “Half Knowledge Can Hurt” with Shadeed Salam

Let's Combinate · 27 Jul 2022 · 1h 14m

What this episode covers

Shadeed Salem, Founder and President of Synergy Bioscience, explains the critical differences between validating test methods for pharmaceutical products versus medical devices. He details how drug methods focus on specificity, linearity, and detecting toxic degradation products (LOD/LOQ), while device methods prioritize physical, mechanical, and visual inspections using Gage R&R. Salem shares a war story about remediating 4,600 OOS investigations by separating R&D and QC labs and validating 136 unverified methods to close an FDA warning letter. He emphasizes that 'half knowledge can hurt' when engineers assume drug and device validation protocols are interchangeable without understanding the underlying regulatory and scientific distinctions.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Synergy Bioscience, Bristol Myers Squibb
Tools
HPLC, FTIR, Mass Spectrometry
Also
FDA, USP, ISO

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