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202206 Ai Summit Logo

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, 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 - Edwards Lifesciences

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

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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