Hardware Podcasts

142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin

Let's Combinate · 26 Jun 2024 · 30m

What this episode covers

Ben Locwin, Executive SME at Black Diamond Networks, discusses material qualification in regulated industries, contrasting the approaches of pharmaceuticals and medical devices with the automotive industry's PPAP and APQP frameworks. He argues that the life sciences sector is too insular, resisting the adoption of proven quality tools like 6 Sigma and Lean that have been used in automotive and aerospace for decades. Locwin emphasizes that regulations are merely the floor for compliance, not the ceiling, and advocates for a skeptical, testing-driven approach to supplier qualification and material compatibility to ensure patient safety.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Black Diamond Networks
Also
AIAG, PPAP, APQP, ISO 10993, IEC 62304, ISO 13485, ISO 14971

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