FDA regulation of Artificial Intelligence/ Machine Learning programs

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Presented By Global Wizdom

Wednesday, September 9th at 1:00pm EST

Online sale ends: 09/09/20 at 12:00pm EST

Live -Webinar

Kellogg Center 26 West Dry Creek Circle, Suite 600

Littleton, CO 80120

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Description

Overview:

This training will address the current regulatory requirements, how they don’t control AI/ML adequately, and approaches FDA is considering for regulation in the near future. Development personnel should understand these concepts because, with some modifications, they will probably become regulations.It is not clear how to get AI/ML programs approved. Following the discussion of possible future regulation, we will discuss, based on recently approved De Novo applications, how to get your AI/ML program approved now.

Areas Covered in the Session:

Total product life cycle approach to AI/ ML design
Application of FDA software Pre Cert program to AI/ ML
FDA discussion paper on AI/ML
Database management
QC of datasets
Algorithm updating
Reference standard development
Standalone performance testing
Clinical performance testing
Data enrichment
Emphasis on “explainability”
Additional labeling requirements
Cybersecurity

Speaker:

Edwin Waldbusser is a consultant retired from industry after 20 years in management of the development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis, and software validation for the past 11 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Tags: AI, Algorithm updating, Artificial Intelligence, Clinical performance testing, Cybersecurity, Data enrichment, FDA Compliance, FDA regulation of Artificial Intelligence, FDA regulation of Machine Learning, FDA Regulations, labeling requirements, Latest Trends in FDA, Machine Learning, ML, product life cycle approach to AI/ ML design, QC of datasets, Reference standard development, regulatory requirements for Artificial Intelligence, regulatory requirements for Machine Learning, Standalone performance testing

Presented By

Time

1:00pm to 2:30pm
Doors open at 12:30pm

Price

General Admission: $159.00

Age

21+

Venue

Live -Webinar<br> Kellogg Center 26 West Dry Creek Circle, Suite 600<br> Littleton, 80120

Capacity

100

Info Line

866-896-1646