Events

The FDA’s Action Plan for AI-ML Based Software as a Medical Device

January 26, 2023
12:00 PM – 1:00 PM

Register now

AdvaMed and EMMA International will host a webinar event: ” The FDA’s Action Plan for AI-ML Based Software as a Medical Device

The FDA’s Action Plan for AI-ML Based Software as a Medical Device

January 26, 2023
12:00 PM – 1:00 PM

Register now

  1. Overview
  2. Speakers

The FDA’s Action Plan for AI-ML Based Software as a Medical Device

January 26, 2023
12:00 PM – 1:00 PM

Register now

Program Overview:

Agenda Topics Include: The Webinar focuses on the recently released FDA’s action plan for regulating AI/ML-based software as a medical device (SaMD). Diving into the five major action items provided in the action plan along with examples that define the actual regulation strategies for AI/ML-based SaMDs

Our live webinar will be recorded. If you are unable to attend, please register and we will follow-up with a recording of the program.

Panelists

Madison Wheeler, CQA

Director of Technical Operations, EMMA International

Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA) and is currently pursuing her M.S. in Quality Management.

Carmine Jabri, PhD, MSJ, MSQM, MHA

CEO, EMMA International

Carmine Jabri, PhD, MSJ, MSQM, MHA is EMMA International’s CEO. His career includes expertise in the Pharmaceuticals, Medical Device and Biologics industries. Dr. Jabri serves on the Food and Drug Law Institute’s Medical Products committee and is an internationally sought-after quality systems expert.

Dr. Jabri holds a Doctor of Philosophy in Epidemiology, a Master of Science in Jurisprudence, a Master of Science in Quality Management, a Master of Science in Health Services Administration, and a Bachelor of Science in Chemistry.

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