# Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices

**Date:** January 15, 2025  
**Time:** 11:00 am EST  
**Duration:** 60 mins

Generative AI devices hold transformative potential for healthcare, but ensuring their safety and effectiveness demands robust lifecycle management strategies. Building on the FDA’s _Total Product Lifecycle Considerations for Generative AI-Enabled Devices_, this session provides actionable insights to help you align with regulatory expectations while driving innovation.

## What you'll learn

- Evidence needs for Generative AI devices, including transparency in training datasets, performance metrics, and validation of off-the-shelf Generative AI used in products
- Postmarket monitoring strategies, such as managing evolving foundation models
- Best practices for dataset management, with a focus on traceability and maintaining quality across the product lifecycle

## Speakers

### Erez Kaminski  
Founder & CEO  
[Ketryx](/content/site-root.html)  
Formerly Head of AI, Amgen

### Jenn Dixon  
Director of AI Quality & Regulatory Strategy  
[Ketryx](/content/site-root.html)  
Formerly

## Clips from this Webinar

## Interested?

[Register now](/content/learn/webinars/register/navigating-the-fdas-total-product-lifecycle-framework-for-generative-ai-devices#register/index.html)