The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems

Foreword

Part 1: Foundation

Chapter 1 Introduction

John Barlow Weiner

Chapter 2 What is a Combination Product?

Susan Neadle

Chapter 3 Regulatory Strategies

Suzette Roan

Chapter 4 cGMPs

Susan Neadle and Mike Wallenstein

Chapter 5 Integrated Development

Susan Neadle

Chapter 6 Risk Management

Susan Neadle, Richard Wedge, and Edwin Bills

Chapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products

Shannon Hoste, Stephanie Canfield, Susan Neadle, Bjorg Hunter, Theresa Scheuble

Chapter 8 Lifecycle Management: Design Transfer through Post Market

Susan Neadle and Khaudeja Bano

Chapter 9

9A. Best Practices and Considerations for Combination Products Inspection Readiness

Susan Neadle

9B. US Combination Product Inspections

Kim Trautman

Part 2: Special Topics

Chapter 10 Supplier Quality Considerations

Fran DeGrazio and Meera Raghuram

Chapter 11 Analytical Testing Considerations

Daniel Bantz and Jennifer Riter

Chapter 12 Biological Products Considerations

Manfred Maeder

Chapter 13 Connected Health

Ryan McGowan

Chapter 14 Evolving Global Regulatory Landscape

Stephanie Goebel, Viky Verna, Chery Marty and Susan Neadle

Appendices

• Comparative Overview of Global Combination Product Regulatory Landscape

Dhiraj Behl and Susan Neadle

• Glossary

Biography

Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. Networked, published, highly active in numerous industry groups and with links to a number of teaching institutions, Susan brings deep knowledge and genuine passion for sharing that knowledge with others. Susan’s leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence. She serves as Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership, technical skills, and complex program management experience to provide international quality & compliance, regulatory, design excellence and executive advisory consulting services to the pharmaceutical, biotech and medical device industries. Among her significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee, lead author on the AAMI Combination Products Steering Committee, active member in Combination Products Coalition, and serves as faculty at AAMI and at University of Maryland Baltimore County Campus College of Natural and Mathematical Sciences for Combination Products Curricula.

Susan retired from Johnson & Johnson, where her distinguished 26+ year-career included integral leadership roles in R&D, Quality Engineering, Design-to-Value, and Quality Systems Management, spanning pharmaceuticals/biotech, medical devices, and consumer health sectors, as well as strategic leadership at J&J corporate level. She served as Chair of J&J’s Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also led J&J's cross-sector Combination Products Community of Practice. Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet Combination Products health authority regulations for Janssen, J&J’s Pharmaceutical sector, and was awarded the Johnson Medal for excellence in Research and Development.

Susan also served as Executive Director and Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development and portfolio/project management from initial clinical investigation through registration and commercial lifecycle. She was as an advisor for internal regulatory policy priorities, health authority engagement and submissions approaches through strategic engagement and mentoring of colleagues for individual projects and portfolio. She led interactions with multiple global health authorities, and served as a catalyst for external consortium deliverables and strategic direction.