Hardware Podcasts

242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start

Let's Combinate · 17 Jun 2026 · 12m

What this episode covers

Subhi Saadeh, founder of Let’s Combinate, outlines six audit strategies from the ASQ Certified Quality Auditor (CQA) Body of Knowledge for pharma, biotech, and combination product audits. He details the Tracing, Process Approach, Process-Based Management, Department, Element, and Discovery methods, explaining how each strategy applies to auditing suppliers, manufacturing sites, or quality systems. Saadeh emphasizes selecting the correct tactic based on whether the goal is verifying evidence, identifying bottlenecks, or surfacing hidden risks.

Most relevant to

early-stage companies

Topics

Mentioned

Also
CQA Academy, ASQ, ISO 9001, ISO 13485

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