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The event titled "Artificial Intelligence (AI), Machine Learning, and the FDA" is an informative online workshop organized by ComplianceIQ. This workshop will delve into the intricate relationship between artificial intelligence technologies and regulatory frameworks provided by the FDA, particularly focusing on the implications for medical devices. The session aims to
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provide crucial insights into the FDA's evolving framework for AI in medical devices, including the roles of verification and validation, as well as the submission requirements for AI-based devices. Participants will learn about the current state of AI algorithms that have received FDA marketing authorization, specifically the difference between 'locked' algorithms and 'adaptive' or 'continuously learning' algorithms that can modify their behavior based on real-world data.
The workshop will also cover essential topics such as the typical software verification and validation protocols, predetermined change control in AI, and the future prospects of AI in medical devices. It will be particularly beneficial for professionals in engineering, research and development, software development, and testing, as well as those involved in the product development processes within FDA-regulated environments. Attendees will gain a comprehensive understanding of the regulatory expectations set forth by the FDA regarding AI and machine learning software in medical applications. The event will emphasize the importance of a manufacturer's change control plan in managing risks associated with modifications to AI algorithms. The session is designed for individuals and organizations working with AI medical devices, including those aiming for compliance with quality management systems and regulatory standards.
John, a consultant from Lincoln and Associates LLC with over 40 years of experience in FDA-regulated industries, will be the key speaker. His expertise spans various roles, including quality assurance, regulatory affairs, and product risk management, making him well-equipped to guide participants through the complexities of validating AI technologies within the framework of FDA regulations. Attendees can expect to receive valuable documentation requirements and insights that will aid in evaluating their current or future AI medical device projects. Overall, this workshop promises to be an essential resource for professionals seeking to navigate the regulatory landscape of AI in healthcare, fostering innovation while ensuring safety and effectiveness.
The workshop will also cover essential topics such as the typical software verification and validation protocols, predetermined change control in AI, and the future prospects of AI in medical devices. It will be particularly beneficial for professionals in engineering, research and development, software development, and testing, as well as those involved in the product development processes within FDA-regulated environments. Attendees will gain a comprehensive understanding of the regulatory expectations set forth by the FDA regarding AI and machine learning software in medical applications. The event will emphasize the importance of a manufacturer's change control plan in managing risks associated with modifications to AI algorithms. The session is designed for individuals and organizations working with AI medical devices, including those aiming for compliance with quality management systems and regulatory standards.
John, a consultant from Lincoln and Associates LLC with over 40 years of experience in FDA-regulated industries, will be the key speaker. His expertise spans various roles, including quality assurance, regulatory affairs, and product risk management, making him well-equipped to guide participants through the complexities of validating AI technologies within the framework of FDA regulations. Attendees can expect to receive valuable documentation requirements and insights that will aid in evaluating their current or future AI medical device projects. Overall, this workshop promises to be an essential resource for professionals seeking to navigate the regulatory landscape of AI in healthcare, fostering innovation while ensuring safety and effectiveness.
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Timings09:00 AM-06:00 PM (expected)Not Verified | Entry FeesCheck Official Website |
Estimated Turnoutupto 100 Delegates | Event TypeWorkshop |
EditionsJun 2025 InterestedFrequency Newly Listed | Official LinksWebsiteContacts Report Error Claim this event |
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ComplianceIQ USA1559 Total Events • 545 Followers | |
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EditionJun 2025
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https://10times.com/hub/medical-pharma-hub
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