Sessions
Article 117 and drug device combination products
5:00 PM - 5:45 PM Wed
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.
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, CE Marking, and Device Regulatory Strategies, Registrations and/or Submissions for device and combination products
• EU MDR/IVDR – Person Responsible for Regulatory Compliance
• ISO 13485:2016/MDSAP
• Regulatory Intelligence and Policy
• 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