# #323 The Combination Products Handbook

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-06-16
- Length: 42m
- Episode: 323
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook
- Listen: https://podcast.greenlight.guru/episode/323-the-combination-products-handbook

## Summary

Susan Neadle, principal consultant and president of Combination Products Consulting Services, discusses her peer-reviewed book, The Combination Products Handbook: A Practical Guide, published by CRC Press. Neadle explains how she collaborated with FDA officials, including John Barwiener, and industry experts from companies like Johnson & Johnson, Novartis, and Pfizer to create a consolidated resource for the complex niche of combination products. The episode details the book's structure, covering regulatory strategies, CGMPs, risk management, and human factors, while highlighting the challenges of harmonizing terminology between pharmaceutical and medical device sectors. Neadle emphasizes the importance of holistic thinking and integrated development to ensure patient safety and regulatory compliance across global jurisdictions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook#t=0) Introduction: Susan Neadle and The Combination Products Handbook
- [4:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook#t=257) Neadle's Career at Johnson & Johnson and Entering Combination Products
- [8:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook#t=487) Multilingual Challenges: Interpreting 'Package' and Supplier Quality
- [11:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook#t=665) Motivation for Writing the Book and FDA Collaboration
- [14:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook#t=893) Book Structure: Regulatory Strategies, CGMPs, and Integrated Development
- [18:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook#t=1136) Risk Management, Human Factors, and Lifecycle Management Chapters
- [26:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook#t=1597) The Handbook as a Practical Reference and Global Harmonization
- [29:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook#t=1765) Future Regulatory Challenges: EPRs, Bridging, and Human Factors
- [33:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook#t=2018) Combination Products as a Growing Niche and Industry Education

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- The Combination Products Handbook: A Practical Guide (product)
- CRC Press (company)
- Johnson & Johnson (company)
- Unilever (company)
- Oregon Scientific (company)
- Janssen Pharmaceutical (company)
- FDA (company)
- ISPE (company)
- ASTM International (company)
- University of Maryland, Baltimore County (company)
- Sanofi (company)
- Novartis (company)
- Pfizer (company)
- Kamionox (company)
- Novo Nordisk (company)
- Janssen (company)
- Amgen (company)
- West Pharmaceutical (company)
- Lubrizol (company)
- AstraZeneca (company)
- XDA (company)
- Routledge (company)
- WHO (company)
- 21 CFR Part 4 (other)
- ICH Q9 (other)
- ISO 14971 (other)
- ASTM TIR 105 (other)
- EU MDR (other)
- CDRH (company)
- CDE (company)

## Related episodes from other shows

- [091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca) (Let's Combinate)
- [022 - "What Chapter are you in?" with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle) (Let's Combinate)
- [204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-03-204-the-dictionary-thesaurus-of-combination-products-finally-explained-with-susa) (Let's Combinate)
- [045 - "Combination Products around the Globe" with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle) (Let's Combinate)
- [152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-04-152-global-medical-device-podcast-interview-behind-the-combinate-podcast-combina) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.