Hardware Podcasts

160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!

Let's Combinate · 30 Oct 2024 · 19m

What this episode covers

Host Subhi Saadeh explains the critical distinctions between drug tech transfer and device design transfer in combination products. He details how drug transfer relies on ICH Q10 for process validation and analytical method transfer, while device design transfer is governed by ISO 13485 and the Device History File (DHF). Saadeh highlights differences in regulatory submissions, such as CMC for drugs versus 510(k) or PMA for devices, and discusses the complexities of synchronizing timelines and supply chains for commercializing combination products.

Most relevant to

established companies

Topics

Mentioned

Also
ICH Q10, ISO 13485, FDA, EMA, 510(k), PMA, PPAP, Larry Mager, Ben Lockwin

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