Workshop
Virtual Sprints: Nov. 4 & 5, 10:00am – 2pm ET
AI Success for Product Approvals and Regulatory Inspections
THIS VIRTUAL WORKSHOP WILL IMMERSE YOU IN A HIGHLY INTERACTIVE EXPERIENCE, SUPPORTED BY VIRTUAL BREAKOUT ROOMS, CHECKBOX Q&A, AND LIVE POLLING — INCLUDING:
Guidance from experts
Tools you can use right away
Case studies that are “real”
Lessons learned for your success
Answers for your greatest challenges
2 concentrated sprints to minimize time away from business critical matters
Recordings of each session will be available to you for three months after the workshop. You will receive login information, slides, and supporting resources prior to the workshop so you are ready to hit the ground running!
Expert Facilitators
Matthew Diamond, M.D., Ph.D
Chief Medical Officer, Digital Health Center of Excellence, FDA-CDRH
Toni Manzano
Co-founder and CSO, Aizon
Bob Banta
Associate Senior Consultant—QA, Eli Lilly
Francisco (Cisco) Vicenty
Program Manager, Case for Quality, Office of Compliance, FDA-CDRH
Phil Pontikos
Head of Regulatory Affairs, Philips CTO, Innovation and Strategy, Philips
Eric Henry
Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
Scott Thiel
Head of Regulatory Policy and Intelligence, Hologic, Inc.
Cynthia A. Ipach
President and CEO, Compliance Insight
Stephen Cook
VP, Quality and Computer Compliance, Compliance Group
Andy Lee
Software Quality Manager, Edwards Lifesciences
Jana Delfino
Assistant Director for Medical Imaging and Digital Health Division of Imaging, Diagnostics, and Software Reliability, Office of Science and Engineering Laboratories, FDA-CDRH
Stephen G. Odaibo, M.D., M.S. (Math), M.S. (Comp. Sci.)
CEO & Founder, RETINA-AI Health, Inc.
Hot Topics, included:
- Discover the evolution of FDA thinking on AI implementation and approvals
- Learn from Eli Lilly on how to build on your current QMS to manage AI
- Building on what you already know: fitting AI into current Quality and Regulatory models
- Understand the migration from computer system validation to computer software assurance
- Develop AI solutions using current regulatory models
- Engage in the Fireside Chat, which will cover establishing trust for AI use in our regulatory landscape
UNLOCK THE POWER OF AI IN YOUR ORGANIZATION.
Unlock the power of AI in your organization. Learn where to start, what to do when Roblox appear, in advance your organization from potential to reality
Who Should Attend?
Bring your data scientist and cross functional Piers explanation you’ll be able to better influence the advancement of your organization if your data scientist in cross functional peers understand the vision, and together you understand the technical realities. No problem if you do not have a data sciences in your organization.
- Quality, regulatory, operations, R&D, clinical trial in supply chain functions
- Regulators and Providers
- Any healthcare industry segment
- Companies of all sizes
- Consultants and service providers to the life science industries
