Breakfast
8:00 AM - 8:45 AM
Tuesday, Nov 7
Welcome & Introductions
8:45 AM - 8:50 AM
Tuesday, Nov 7
How is FDA Supporting Manufacturing Innovation and Advanced Technologies? Plenary Keynote
8:50 AM - 9:35 AM
Tuesday, Nov 7
A Fireside Chat With Our Keynote Speaker
9:35 AM - 10:20 AM
Tuesday, Nov 7
The Catalyst to More Successful Mexico-based Operations - TechTalk
10:20 AM - 10:35 AM
Tuesday, Nov 7
Networking Break
10:35 AM - 10:50 AM
Tuesday, Nov 7
What Does Advanced Manufacturing Mean to MedTech?
10:50 AM - 11:20 AM
Tuesday, Nov 7
Do or Do Not...There is No Try in Digital Transformation
11:20 AM - 12:05 PM
Tuesday, Nov 7
Managing Medical Products Across the Product Lifecycle
11:20 AM - 12:05 PM
Tuesday, Nov 7
Lunch
12:05 PM - 1:15 PM
Tuesday, Nov 7
Impact of AI and ML on QMS: A Perspective on Developing Products and Internal Tools for Efficiency
1:15 PM - 2:00 PM
Tuesday, Nov 7
FDA and Advanced Manufacturing Technologies: Latest efforts in Communication, Training, and Guidance
2:00 PM - 2:45 PM
Tuesday, Nov 7
Modern Regulatory Information Management for MedTech - TechTalk
2:45 PM - 3:00 PM
Tuesday, Nov 7
Networking Break
3:00 PM - 3:15 PM
Tuesday, Nov 7
Goodbye Computer System Validation, Hello Computer Software Assurance!
3:15 PM - 4:00 PM
Tuesday, Nov 7
A Panel Discussion with FDA Regulators
4:00 PM - 4:45 PM
Tuesday, Nov 7
TechTalk
4:45 PM - 5:00 PM
Tuesday, Nov 7
Networking Reception
5:00 PM - 6:00 PM
Tuesday, Nov 7
Networking Breakfast
8:00 AM - 8:45 AM
Wednesday, Nov 8
Welcome/Introductions/Conference Announcements
8:45 AM - 8:50 AM
Wednesday, Nov 8
Digital Transformation Efforts at FDA CDRH
8:50 AM - 9:35 AM
Wednesday, Nov 8
eQMS: A Competitive Advantage for a World-Class Quality System
9:35 AM - 10:20 AM
Wednesday, Nov 8
Product Lifecycle Management in the Medical Device Industry: Navigating Challenges for Success - TechTalk
10:20 AM - 10:35 AM
Wednesday, Nov 8
Networking Break
10:35 AM - 10:50 AM
Wednesday, Nov 8
Applying ASME VVUQ40 Standard Framework for Assessing the Utility and Value of Predictive Models in Additive Manufacturing
10:50 AM - 11:20 AM
Wednesday, Nov 8
Overcoming Advanced Manufacturing Challenges & Opportunities
11:20 AM - 12:05 PM
Wednesday, Nov 8
Advanced Manufacturing Conference Close
12:05 PM - 12:10 PM
Wednesday, Nov 8
Welcome Lunch - Supply Chain Conference
12:05 PM - 1:15 PM
Wednesday, Nov 8