COURSE - INSTANT STREAMING ACCESS
.addeventatc { background-color:#49b40c!important; color:#ffffff!important; font-size:13px!important; padding:6px 20px 6px 12px!important; /* extra right padding for icon */ border-radius:6px!important; display:inline-flex!important; align-items:center!important; gap:6px!important; /* spacing between text and icon */ position:relative!important; } /* Icon fix */ .addeventatc .addeventatc_icon { position:absolute!important; right:10px!important; /* push icon to right edge */ width:12px!important; height:12px!important; background:url(https://cdn.addevent.com/libs/imgs/icon-calendar-fff-t1.svg) no-repeat center center!important; background-size:14px!important; }
Share:

FDA's Q-Submission Program for Medical Devices, SiMD / SaMD with Considerations for Using AI and ChatGPT

This course equips regulated industry professionals to structure FDA Q-Sub interactions, manage AI and SaMD regulatory expectations, and strengthen submission quality using current FDA processes, eSTAR workflows, and software validation practices that reduce avoidable review delays and development setbacks. This Course is designed for professionals managing regulated medical device software, submissions, validation, quality, compliance, and lifecycle activities.

REGISTER FOR THE COURSE

US $190 per learner

30-Days Unlimited Streaming Access

/* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } /* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } .accordion-header::after { content: "◯"; font-size: 18px; transition: transform 0.25s ease; } .accordion-item.active .accordion-header::after { transform: rotate(90deg); }

REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
/* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } /* Hide default + / - icon */ .accordion-toggle-icon { opacity: 0; } /* Add circle instead */ .accordion-header::after { content: "○"; font-size: 18px; margin-left: auto; transition: 0.2s ease; } /* When open → filled circle */ .accordion-item.active .accordion-header::after { content: "●"; } .accordion-header::after { content: "◯"; font-size: 18px; transition: transform 0.25s ease; } .accordion-item.active .accordion-header::after { transform: rotate(90deg); }
  • Instructor : Carolyn Troiano
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF1342
  • Assessment & Certification Included
  • Ask the Expert

Watch the Course Now  

Watch the Course Now   

About the Course

FDA’s Q-Submission program has become increasingly important for companies developing medical devices, SaMD products, and software-enabled technologies that involve AI, ML, and LLM capabilities. The process provides manufacturers with formal pathways for obtaining FDA feedback before submission, helping organizations address technical, regulatory, and review concerns earlier in development. For novel and higher-risk products, particularly AI-enabled software applications, early interaction with FDA can reduce unnecessary review cycles and improve submission quality.


Recent FDA modernization efforts, including expanded use of generative AI and electronic submission tools such as eSTAR, are changing how submissions are prepared and reviewed. Organizations developing software-driven products must now address evolving expectations for software validation, maintenance, risk management, and predetermined change control planning. Clear understanding of Q-Sub mechanisms, submission pathways, and FDA expectations has become increasingly important for maintaining compliant and efficient product development programs.

  • Practical Direction for FDA Q-Submission Planning:

    Participants will gain practical understanding of how to prepare and use Q-Sub pathways for medical devices, software-enabled products, and SaMD applications. The course clarifies FDA expectations for meetings, written requests, submission issues, and PCCP-related discussions, helping organizations reduce uncertainty before formal submissions and avoid preventable delays during review cycles.

  • Operational Insight Into AI, ChatGPT and Software Validation Expectations:

    The course explains how AI, ML, and LLM technologies such as ChatGPT are influencing software development, validation, maintenance, and FDA review activities. Participants will better understand current operational risks, data reliability concerns, and evolving regulatory expectations affecting software-based medical products, particularly as FDA increases use of generative AI within submission review processes.

Key Areas Covered

  • FDA Q-Submission program structure, purpose, and use for medical devices, software-enabled devices, and SaMD products
  • Pre-Submission requests, Submission Issue Requests, Informational Meetings, Day 100 Meetings, and Study Risk Determinations
  • Use of eSTAR and FDA submission portal workflows for electronic regulatory submissions and interactive templates
  • Predetermined Change Control Plan (PCCP) considerations for AI/ML-enabled medical devices and software modifications
  • Software validation and maintenance expectations for SaMD products and devices containing software components
  • FDA use of AI, ML, and LLM technologies, including ChatGPT, within submission review and operational processes
  • Industry risks and operational concerns associated with AI, ML, and LLM technologies trained on unreliable datasets
  • 21 CFR Part 11 considerations and current FDA guidance affecting electronic records, submissions, and software compliance

Who Must Attend

  • QA/QC Departments
  • Information Technology Analysts
  • Laboratory Managers
  • Regulatory Affairs Departments
  • Compliance Professionals
  • Clinical Data Managers

Quality training, expert insights, and answers that matter. Know your Expert

CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience supporting computer system validation and large-scale IT implementation projects within pharmaceutical, medical device, animal health, tobacco, and other FDA-regulated industries. Her background includes development of validation strategies, collaboration with FDA and industry representatives on 21 CFR Part 11, and advisory work involving software compliance and regulated systems. Her experience directly supports the regulatory, software validation, and submission process topics.

If you would like to request a Proforma invoice to sign up for this course. please click here

Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

Upcoming Courses

Your TalkFDA Webinar Experience

When you reserve your seat, everything is organized for you — from access to certification from one place.

1. Confirmation
You receive a confirmation email and your course appears instantly in your TalkFDA dashboard.

2. Your Course Hub
Your TalkFDA course page becomes your central hub where you can watch the course, access materials, and manage your learning.

3. Access course materials
The presentation handout and other materials can be downloaded inside the Course Player. You could use Discussion feature there to ask your questions.

4. Watch The Streaming and Complete your Course
The course playback will be available on the same course page. You could pause and continue or you can revisit important sections.
5. Earn Your Certificate
Complete the course and your certificate is unlocked automatically in your learning history.

The challenge with training is rarely signing up. It’s what happens afterward, when access, materials, & certification aren’t accessible from one place.
With TalkFDA Courses, Everything you need Live in One Place.
Simple. Organized. Professional.
Go ahead and Take the Course with confidence.

Our students love us ❤️

“Pre-session communication was smooth. No confusion on access or timing.”



Regulatory Affairs Manager

“Content felt organized with a clear purpose instead of just moving through slides.”



Quality Assurance Specialist

“Format was straightforward and easy to follow. We’d consider future sessions.”



Director, Regulatory Affairs

People who took this Course, also viewed