Susan W. Neadle FRAPS, FAAO

Susan Neadle, MS, BS, FRAPS, FAAO is a recognized international Combination Products and Medical Device expert with over 30 years industry experience. Susan is well networked and highly active in numerous industry groups with links to multiple teaching institutions. Her leadership, innovation, and best practices have been recognized with several awards, including Fellowship in the Regulatory Affairs Professional Society (RAPS), the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Awards Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development. She has recently published the FDA peer-reviewed and AAMI-endorsed book, “The Combination Products Handbook: A Practical Guide” through CRC Press (www.routledge.com/9781032291628). Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, applying her extensive leadership, technical skills and experience to provide international quality, regulatory affairs, executive advisory 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 TIR 48 Combination Product cGMP standard revision. 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 and steering committees including AFDO/RAPS, DIA, CPC, TOPRA and PQRI, and enjoys speaking at a variety of industry forums. Susan can be reached at sneadle@combinationprod.com.