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FDA REGULATION OF ARTIFICIAL INTELLIGENCE/ MACHINE LEARNING

By: Edwin Waldbusser

24 April, 2023 (Monday)

Duration: 60 Minutes

Timing: 12:00 PM PDT | 03:00 PM EDT

Countdown:

 * 10 : Days
 * 03 : Hrs
 * 20 : Min
 * 46 Sec

 * OVERVIEW
 * WHY SHOULD YOU ATTEND
 * AREA COVERED
 * WHO WILL BENEFIT?

AI/ ML will revolutionize medicine by making diagnosis and treatment more
accessible and more effective.
FDA has regulated medical software by means of regulations and guidance for
years, however, AI/ML programs fall outside the scope of these regulations and
guidances.

This happens because FDA approves the final, validated version of the software.
The point of AI/ML is to learn and update following deployment to improve
performance. Thus the field version of the software is no longer the validated
approved version.

We will discuss the current regulatory requirements, how they don’t control
AI/ML adequately, and approaches FDA is considering for regulation in the near
future. Your development program should conform to these concepts now because,
with some modifications, they will probably become regulations.

Following a discussion of possible future regulations, we will discuss, based on
recently approved De Novo applications, how to get your AI/ML program approved
now. Necessary submission documentation will be explained.

This webinar is not a programming course but will explain the present and future
regulatory requirements for AI/ML.

WHY SHOULD YOU ATTEND

 * It is not clear how to get AI/ML programs approved. The current regulatory
   requirements don’t control AI/ML adequately.
 * We will discuss the approaches FDA is considering for regulation in the near
   future and how to get your AI/ML program approved by FDA now.
 * Necessary submission documentation will be explained Attendees will receive a
   multipage outline and checklist.

AREA COVERED

 * 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

WHO WILL BENEFIT?

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

 * Software Engineers
 * Engineers
 * Regulatory Personnel
 * Quality Assurance Personnel
 * Marketing
 * Management

 * It is not clear how to get AI/ML programs approved. The current regulatory
   requirements don’t control AI/ML adequately.
 * We will discuss the approaches FDA is considering for regulation in the near
   future and how to get your AI/ML program approved by FDA now.
 * Necessary submission documentation will be explained Attendees will receive a
   multipage outline and checklist.

 * 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



Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

 * Software Engineers
 * Engineers
 * Regulatory Personnel
 * Quality Assurance Personnel
 * Marketing
 * Management

  Download Brochure   Set Email Reminder



Live Webinar Options:
(Live Session for 1 Participant)
Live Session ($199)


INCREASE PARTICIPANTS

1 Participants $199 2 Participants $299 3 Participants $399 4 Participants $449
5 Participants $499 6 Participants $549 7 Participants $599
(Live + Recorded Session)
Super Jumbo Offer ($269)
(Live + Transcript)
Live + Transcript ($249)
(Live + Training CD)
Super Jumbo Offer ($450)
On Demand Options:
(PDF Transcript of Training)
Transcript ($179)
(Downloadable Recorded session)
Recorded session ($239)
(Training CD)
Training CD ($350)
Group Session Options:
(Group Session Participants + Recorded)
Group Session for 10 Participants($799)

For adding extra attendees please contact our Customer Support Team


$


For multiple location please contact our customer care team Tel:+1-661-336-9555

April 14, 2023

Zero Acceptance Sampling to Reduce Inspection Costs

William A. Levinson

SPEAKER PROFILE



Edwin Waldbusser
View All Webinars

Edwin Waldbusser, is a consultant retired from industry after 20 years in
management of development of medical devices (5 patents). He has been consulting
in the areas of design control, risk analysis and software validation for the
past 8 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.



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