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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-06-28
- Length: 40m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/091---Combination-Products-Handbook-Part-1-Foundation--Learning-from-the-process--Case-Studies-and-Book-QA-with-Susan-Neadle-e2647nh

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca#t=0) Introduction: Subhi Saadeh and Susan Neadle
- [3:28](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca#t=208) Editorial Approach and Multi-Expert Collaboration
- [6:29](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca#t=389) Making the Handbook Evergreen Amidst Regulatory Changes
- [9:25](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca#t=565) CGMPs: US vs. EU Regulatory Frameworks
- [15:23](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca#t=923) History of Combination Products and Pre-filled Syringe Case Study
- [19:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca#t=1140) Regulatory Submissions: DMFs, MAFs, and CTDs
- [23:44](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca#t=1424) Integrating ICH Q9 and ISO 14971 for Risk Management
- [30:17](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca#t=1817) Human Factors and Unique Combination Product Case Studies
- [33:05](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca#t=1985) Post-Market Safety Reporting and Design Transfer
- [36:43](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca#t=2203) Inspection Readiness and FDA Compliance Programs

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)

## Most relevant to

established companies

## Mentioned

- Combination Products Consulting Services LLC (company)
- The Combination Products Handbook: A Practical Guide (other)
- Taylor & Francis Group (company)
- Johnson & Johnson (company)
- FDA (other)
- ISO 14971 (other)
- ICH Q9 (other)
- EU MDR (other)

## Related episodes from other shows

- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#422: ISO 14971 and the Road to Risk Management with Edwin Bills](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills) (Global Medical Device Podcast)
- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)

## Citing this page

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