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Aisummit 2023 Horz

AI Summit 2023 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

Invited 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, Investigator, Medical Device National Expert, FDA-OMDRHO-ORA
Phil Pontikos
Head of Regulatory Affairs, Philips CTO, Innovation and Strategy, Philips

Eric Henry, King & Spalding
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.

Engage in Hot Topics, including:

  • 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

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

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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