Hardware Podcasts

022 - "What Chapter are you in?" with Susan Neadle

Let's Combinate · 2 Mar 2022 · 1h 23m

What this episode covers

Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and former Head of Combination Products at Amgen and Johnson & Johnson, discusses the regulatory and engineering challenges of combination products. She details the implementation of 21 CFR Part 4, the importance of harmonizing terminology between drug and device sectors, and her work with standards bodies like ASTM and AAMI on TIR 48 and TIR 105. Neadle explains her strategic planning frameworks, including the Merlin Exercise and Design to Value, to navigate complex quality systems and global regulatory differences.

Most relevant to

established companies

Topics

Mentioned

Companies
Johnson & Johnson, Amgen, Unilever, IBM, FDA, Genus
Also
21 CFR Part 4, ASTM, AAMI, TIR 48, TIR 105, ISPE

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