Navigating FDA’s AI/ML Regulations: How to Stay Compliant as Your Systems Evolve?
AI/ML Compliance Gaps Could Cost You—Insider Techniques for Staying Compliant!
Instructor :
Jose Mora
Webinar ID:
11813
Date: FEB 24, 2025 (MON)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
⚙️ The FDA Compliance & Validation Strategies Bundle (3 Courses)
“Optimize Your Processes and Ensure Compliance in FDA-Regulated Industries!”
Courses Included:
-
- 2025 FDA & ISO Process Validation Mastery: Advanced Process Validation for Global Regulatory Alignment (duration 90 mins.), find out more details here
- Compliance Chaos or Control? Master Change Control & Optimize Regulatory Assessments (duration 90 mins.), find out more details here
- Navigating FDA’s AI/ML Regulations: How to Stay Compliant as Your Systems Evolve? (duration 90 mins.), find out more details here
This Bundle Empowers You To:
-
- Enhance Process Validation: Implement effective validation strategies to meet FDA requirements.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
⚙️ The FDA Compliance & Validation Strategies Bundle (3 Courses)
“Optimize Your Processes and Ensure Compliance in FDA-Regulated Industries!”
Courses Included:
-
- 2025 FDA & ISO Process Validation Mastery: Advanced Process Validation for Global Regulatory Alignment (duration 90 mins.), find out more details here
- Compliance Chaos or Control? Master Change Control & Optimize Regulatory Assessments (duration 90 mins.), find out more details here
- Navigating FDA’s AI/ML Regulations: How to Stay Compliant as Your Systems Evolve? (duration 90 mins.), find out more details here
This Bundle Empowers You To:
-
- Enhance Process Validation: Implement effective validation strategies to meet FDA requirements.
- Master Change Control: Navigate the complexities of regulatory impact assessments during changes.
- Leverage Emerging Technologies: Understand FDA regulations concerning AI and ML to innovate responsibly.
Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!
Buy All 3 Courses at a 35% discount HERE
What will you learn
-
- Determine Required Number Of Participants For Validation Study
- Select Appropriate Tasks To Validate AI/ML Program
- Define Qualitative Success Criteria For Validation
- Develop Comprehensive Validation Protocol For Testing
- Conduct Validation Tests Following Established Protocol
- Gather Post-Test Participant Feedback Using Inquiry Forms
- Compile Usability Validation Tracking Matrix For ….
-
- Determine Required Number Of Participants For Validation Study
- Select Appropriate Tasks To Validate AI/ML Program
- Define Qualitative Success Criteria For Validation
- Develop Comprehensive Validation Protocol For Testing
- Conduct Validation Tests Following Established Protocol
- Gather Post-Test Participant Feedback Using Inquiry Forms
- Compile Usability Validation Tracking Matrix For Analysis
- Prepare Validation Test Results Report For Review
- Provide Validation Test Results Report As Handouts
Course Description
AI/ML is set to revolutionize medicine by making diagnosis and treatment more accessible and effective.
While the FDA has regulated medical software through various regulations and guidance, AI/ML programs currently fall outside these traditional frameworks.
This is because the FDA approves the final, validated version of software. However, AI/ML programs are designed to learn and update post-deployment, meaning the field version often deviates from the originally approved version.
Key Highlights of This Webinar:
-
- Understand the current regulatory requirements and why they fall short in adequately controlling AI/ML.
- Explore the approaches the FDA is considering for future regulation.
- Learn how to align your development program with upcoming regulatory concepts to ensure future compliance.
- Insight into recently approved De Novo applications and strategies for getting your AI/ML program approved now.
- Detailed explanation of the necessary submission documentation for AI/ML approval.
This webinar is not a programming course but will provide a deep dive into the present and future regulatory requirements for AI/ML. Stay ahead of the curve and ensure your AI/ML solutions are FDA-compliant!
Join Now!
AI/ML is set to revolutionize medicine by making diagnosis and treatment more accessible and effective.
While the FDA has regulated medical software through various regulations and guidance, AI/ML programs currently fall outside these traditional frameworks.
This is because the FDA approves the final, validated version of software. However, AI/ML programs are designed to learn and update post-deployment, meaning the field version often deviates from the originally approved version.
Key Highlights of This Webinar:
-
- Understand the current regulatory requirements and why they fall short in adequately controlling AI/ML.
- Explore the approaches the FDA is considering for future regulation.
- Learn how to align your development program with upcoming regulatory concepts to ensure future compliance.
- Insight into recently approved De Novo applications and strategies for getting your AI/ML program approved now.
- Detailed explanation of the necessary submission documentation for AI/ML approval.
This webinar is not a programming course but will provide a deep dive into the present and future regulatory requirements for AI/ML. Stay ahead of the curve and ensure your AI/ML solutions are FDA-compliant!
Join Now!
Why you should attend
In the rapidly evolving landscape of Artificial Intelligence and Machine Learning in healthcare, staying compliant with FDA regulations is no longer optional—it’s essential.
As the FDA is actively working to create a regulatory framework for AI/ML, understanding these changes is crucial for ensuring your programs remain both innovative and compliant.
Why This Webinar is a Must-Attend:
-
- Navigate Uncertainty: With AI/ML still in a regulatory gray area, many professionals are unsure how to secure FDA approval. This webinar will demystify the process, providing you with a clear pathway to compliance.
- Anticipate Future Regulations: The FDA is already considering new approaches for regulating AI/ML. By understanding these potential changes now, you’ll be better equipped to future-proof your programs and avoid costly rework down the line.
- Immediate Application: Learn practical strategies and gather insightful knowledge that you can immediately apply to your job role, ensuring your AI/ML programs align with current and upcoming regulations.
- Boost Your Expertise: Stand out in your field by mastering the intricacies of AI/ML regulation. This expertise will not only make you a valuable asset to your organization but also position you as a leader in the AI/ML regulatory space.
- Exclusive Tools and Resources: Gain access to a multipage outline and checklist designed to guide you through the FDA approval process step-by-step, saving you time and reducing the risk of errors in your submission.
By attending this webinar, you’ll be equipped to:
-
- Proactively address regulatory challenges and ensure compliance.
- Develop AI/ML programs that are not only cutting-edge but also FDA-ready.
- Enhance your career by becoming a go-to expert on FDA regulations for AI/ML.
Don’t let regulatory hurdles hold back your innovations. Join us to gain the knowledge and tools you need to successfully navigate the evolving FDA landscape for AI/ML.
Enroll Now!
In the rapidly evolving landscape of Artificial Intelligence and Machine Learning in healthcare, staying compliant with FDA regulations is no longer optional—it’s essential.
As the FDA is actively working to create a regulatory framework for AI/ML, understanding these changes is crucial for ensuring your programs remain both innovative and compliant.
Why This Webinar is a Must-Attend:
-
- Navigate Uncertainty: With AI/ML still in a regulatory gray area, many professionals are unsure how to secure FDA approval. This webinar will demystify the process, providing you with a clear pathway to compliance.
- Anticipate Future Regulations: The FDA is already considering new approaches for regulating AI/ML. By understanding these potential changes now, you’ll be better equipped to future-proof your programs and avoid costly rework down the line.
- Immediate Application: Learn practical strategies and gather insightful knowledge that you can immediately apply to your job role, ensuring your AI/ML programs align with current and upcoming regulations.
- Boost Your Expertise: Stand out in your field by mastering the intricacies of AI/ML regulation. This expertise will not only make you a valuable asset to your organization but also position you as a leader in the AI/ML regulatory space.
- Exclusive Tools and Resources: Gain access to a multipage outline and checklist designed to guide you through the FDA approval process step-by-step, saving you time and reducing the risk of errors in your submission.
By attending this webinar, you’ll be equipped to:
-
- Proactively address regulatory challenges and ensure compliance.
- Develop AI/ML programs that are not only cutting-edge but also FDA-ready.
- Enhance your career by becoming a go-to expert on FDA regulations for AI/ML.
Don’t let regulatory hurdles hold back your innovations. Join us to gain the knowledge and tools you need to successfully navigate the evolving FDA landscape for AI/ML.
Enroll Now!
Areas Covered
-
- Required Number of Participants
- Choice of Tasks to Validate
- Qualitative Success Criteria
- Validation Protocol
- Post-Test Participant Inquiry (Includes Usability Validation Tracking Matrix)
- Validation Test Results Report (Provided as Handouts)
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
-
- Required Number of Participants
- Choice of Tasks to Validate
- Qualitative Success Criteria
- Validation Protocol
- Post-Test Participant Inquiry (Includes Usability Validation Tracking Matrix)
- Validation Test Results Report (Provided as Handouts)
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Who is this course for
The following benefits from watching this. Even better when done as a group!
-
- Regulatory Affairs Manager
- Quality Assurance Specialist
- Clinical Research Scientist
- Medical Device Developer
- AI/ML Compliance Officer
- Healthcare Data Scientist
- Product Development Manager
- FDA Regulatory Consultant
- Biomedical Engineer
The following benefits from watching this. Even better when done as a group!
-
- Regulatory Affairs Manager
- Quality Assurance Specialist
- Clinical Research Scientist
- Medical Device Developer
- AI/ML Compliance Officer
- Healthcare Data Scientist
- Product Development Manager
- FDA Regulatory Consultant
- Biomedical Engineer
Instructor Profile
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.
Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, Kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership.
He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
