James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 25 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas. James received his undergraduate and graduate degrees from Duquesne University and received his Health Care Compliance Certificate from Seton Hall University Law School. He is a member of various regulatory and quality work groups including RAPS, OCRA and the ASQ Orange Empire Section.

Carolyn Dorgan has 15+ years experience in the medical device and combination product industries, including seven years at the US Food and Drug Administration (FDA) leading the Infusion Devices team. She currently serves as one of the Directors of Technical Services at Suttons Creek helping companies in the combination product space solve challenging regulatory, quality and organizational challenges. She implements practical solutions using her multi-disciplinary background of engineering, software, cybersecurity, human factors and business. Carolyn has a BS in Biomedical Engineering from the University of Minnesota and an MS in Technology Commercialization from the University of Texas.

Jerzy Wojcik is VP of Quality and Regulatory Affairs Services at EdgeOne Medical Inc. He is a senior regulatory and quality executive with 26+ years of experience guiding medical device and drug-device combination product programs through global development, clinical readiness, and lifecycle management. He is recognized for translating complex global regulatory and quality requirements into executable development, clinical, and lifecycle strategies that support product approval, commercialization, and sustained compliance. He is a trusted advisor to sponsors, investors, and legal counsel on development readiness, risk management, and regulatory strategy for high-risk and innovative technologies.