Hardware Podcasts

168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth

Let's Combinate · 25 Dec 2024 · 13m

What this episode covers

Subhi Saadeh, host of Let's Combinate and Quality Professional, discusses the parallel between Peter Drucker’s book 'Managing Oneself' and the role of audits in pharma and medical device industries. He explains the three levels of audits—first-party (internal), second-party (supplier), and third-party (regulatory/certification)—and their specific purposes in ensuring compliance with regulations like ISO 13485 and 21 CFR Part 4. Saadeh emphasizes that audits are systematic, evidence-based appraisal activities designed to reveal system weaknesses and build trust with regulators and patients, rather than just catching mistakes.

Most relevant to

early-stage companies

Topics

Mentioned

Also
Let's Combinate, Managing Oneself, Peter Drucker, ISO 13485, FDA, 21 CFR Part 4, ISO 19011

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