Hardware Podcasts

091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle

Let's Combinate · 28 Jun 2023 · 40m

What this episode covers

Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and author of The Combination Products Handbook, joins host Subhi Saadeh to discuss the book's creation, structure, and key technical content. They explore the challenges of coordinating multiple global experts to create an 'evergreen' resource that addresses the complexities of combination products, including injectors and on-body devices. Neadle details specific regulatory strategies, such as the integration of ICH Q9 and ISO 14971 for risk management, and the nuances of CGMPs under US and EU frameworks. The conversation highlights case studies, human factors testing, and post-market surveillance best practices derived from industry experience and FDA collaboration.

Most relevant to

established companies

Topics

Mentioned

Companies
Combination Products Consulting Services LLC, Taylor & Francis Group, Johnson & Johnson
Also
The Combination Products Handbook: A Practical Guide, FDA, ISO 14971, ICH Q9, EU MDR

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