Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.
James Wabby, Executive Director, Regulatory Affairs, Devices and Combination Products, Allergen
James has over 15 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. He regularly provides Allergan therapeutic franchise units regulatory counsel to all aspects within the quality management system arena pertaining to medical devices and combination products regarding:
• Regulatory Affairs – CMC Global Dossiers and Device Regulatory Strategy Registrations
• MDR/IVDR – Person Responsible for Regulatory Compliance
• ISO 13485:2016/MDSAP
• Product Development – Design Controls
• Risk Management
• Human Factors Engineering
• Acquisitions/Divestitures
• Import/Export – U.S. Agent
• CAPA
• Production Controls
• Regulatory Inspection Management
• Materiovigilance
• Health-Care Related Laws and International Regulations
James has a BSc. in Biology from Duquesne University, an MHMS in Health Law/Policy and Medical Informatics from Duquesne University, and a Health Care Compliance Certificate from Seton Hall University Law School. He is a member of various regulatory and quality work groups including RAPS, AAMI, AHLA and the ASQ Orange Empire Section.