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

On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss: Part 1 of The Combination Products Handbook: A Practical Guide to Combination Products and Other Combined Use Systems: Foundation Subhi's questions on each chapter What she learned from authoring and coordinating of the book Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience.  She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press.   Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development.  Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries.    She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees.  Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request.  She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums.   Susan can be reached at [email protected].