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Effective URL: https://instructorsclub.com/fda-regulation-of-artificial-intelligence-machine-learning/1752?through=Albert14thAprS
Submission: On April 14 via manual from US — Scanned from DE
Effective URL: https://instructorsclub.com/fda-regulation-of-artificial-intelligence-machine-learning/1752?through=Albert14thAprS
Submission: On April 14 via manual from US — Scanned from DE
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info@instructorsclub.com Tel:+1-661-336-9555 Register Login * Home * About Us * Webinars * Seminars * Membership * Blog * Contact * * View Cart 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. DOWNLOAD BROCHURE × Close SET YOUR REMINDER × Close × Close SUBSCRIBE TO OUR NEWSLETTER For our latest blogs and news, stay updated with us! 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