James Wabby MTOPRA AbbVie

James P. Wabby, MHMS, is Head, Global Regulatory Affairs–(CoE) (Emerging Technologies, Combination Products, and Medical Devices) at AbbVie, Inc. He has over 23 years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP-regulated environment pertaining to medical device, technology medicinal delivery platforms, complex generics, companion diagnostics, digital medicine, and combination product areas. James is also an Adjunct Assistant Professor at USC School of Pharmacy–Regulatory and Quality Sciences and an international speaker, chair, and keynote at various symposia, Chairman of the DIA Combination Products Committee, and a moderator for various global regulatory panel discussions. He has a BSc in biology and MHMS in health law and policy from Duquesne University. He has been an ISPE member since 2020. Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system arena and regulatory affairs. He is a member of various regulatory work groups including DIA, RAPS, RAPS/AFDO, AAMI, ISPE, OCRA, SDRAN, ASQ Orange Empire Section, and ASQ San Diego.