Two-day course · in Stoughton, MA or at your Facility
Using AI Safely in Regulated Life Sciences: Protecting Patient Data and Proprietary Information
Give your team a shared, practical framework for what staff may and may not do with AI tools, and leave with the documents to prove it.
- Next available dates
- Jan 6 and 8, or Jan 20 and 22, 2027 (Wed and Fri)
- Time
- 9:00 am to 4:00 pm, 13 instructional hours
- Place
- 6 Cabot Place, Suite 5, Stoughton, MA
- Fee
- $2,000 per participant
Who it is for
QA, regulatory affairs, validation, and clinical operations leads, and their managers, at Massachusetts life science companies who are being asked what staff may and may not do with AI tools.
It also suits manufacturing and data staff at biotech, pharmaceutical, medical device, and CDMO companies who use, evaluate, or approve AI tools. No programming background is required.
Teams get the most from it together. Consider sending 3 to 6 people from one company so the policy decisions get made in the room.
What participants leave with
- Several written tools and techniques that can be reused
Participants will work to build these in class from templates.
What the two days cover
Data boundaries
Which types of data may and may not be entered into AI tools, and how to protect patient, participant, and proprietary or confidential information.
Vendors and tools
Questions to ask when evaluating AI vendors and tools before your team uses them.
What FDA expects
Documentation and data integrity expectations, including electronic records under 21 CFR Part 11, and how FDA's draft guidance on AI to support regulatory decision-making frames risk and credibility for a defined context of use.
How it is taught: case-based, with exercises on realistic scenarios, including a prompt and data-handling review and a vendor-checklist review.
Your instructor
Dr. Leona Saunders has taught graduate-level regulatory science at several universities for more than 19 years, including courses in FDA law and AI in regulatory science. She brings more than 25 years of experience in FDA-regulated product development.
This course does not provide legal advice, security certification, or consulting services.
Learning objectives
- 1Identify the categories of data that should never be entered into public or unapproved AI tools.
- 2Explain how patient privacy and proprietary-information risks arise when using AI tools.
- 3Apply a checklist to evaluate an AI tool or vendor before use.
- 4Draft a team AI-use policy and a data-handling decision tree from templates.
- 5Describe FDA's draft risk-based credibility approach to AI used in regulatory decision-making, including what a context of use is.
- 6Recognize documentation and data integrity expectations for AI-assisted work, and know when to involve legal, privacy, and security specialists.
Dates, location, and fee
Sessions
- Option 1: Wednesday and Friday, January 6 and 8, 2027
- Option 2: Wednesday and Friday, January 20 and 22, 2027
- 9:00 am to 4:00 pm each day
Location: IRSG classroom, 6 Cabot Place, Suite 5, Stoughton, Massachusetts. Free parking, and a light lunch is provided.
On-site training at your facility is available for groups. Grant funding applies to on-site sessions if approved.
Fee
$2,000 per participant
The class runs if at least 6 seats are paid one week before the session. Otherwise, you may transfer to the next session or receive a full refund. Group and on-site pricing are available on request.
State funding for Massachusetts employers
Massachusetts employers with 100 or fewer Massachusetts W-2 employees may apply to the Workforce Training Fund.
How it works
- 1Your company submits its Express application at least 21 days before the first session. We recommend 28.
- 2You pay IRSG directly.
- 3After training is completed and paid in full, you submit a reimbursement request with the signed form, trainee list, our invoice, and proof of payment.
Approval is decided by the Commonwealth and is not guaranteed. Your company pays first and is reimbursed afterward, so plan your cash flow.
Application deadlines
| Session | Recommended | Program minimum |
|---|---|---|
| January 6 and 8, 2027 | December 9, 2026 | December 16, 2026 |
| January 20 and 22, 2027 | December 23, 2026 | December 30, 2026 |
Session frequency: Sessions run twice per month.
Application help: IRSG will spend up to 30 minutes with you on the application at no charge.
Program rules can change. Confirm current requirements with the Commonwealth before you apply.
Questions
Innovative Regulatory Science Group, LLC
6 Cabot Place, Suite 5, Stoughton, MA 02072 | 617-213-1600
Contact: Tyrone Williams, MBA, PMP
Director of Business Development | tyrone@regsci.com
© 2026 Innovative Regulatory Science Group, LLC. This course does not provide legal advice, security certification, or consulting services. The Commonwealth does not endorse any training provider or course.