Basic Principles of AI-enabled Computerized Systems Compliance: Applying the GAMP® AI Guide (T77)
Overview
GAMP® AI guidance provides a pragmatic and effective framework for achieving AI-enabled computerized systems that are fit for intended use and aligned with current regulatory expectations. This course introduces participants to the requirements for AI-enabled computerized systems and internationally recognized methods of meeting those requirements.
Participants will be equipped to apply a pragmatic, cost-effective good practice framework that supports the development of AI-enabled computerized systems that are high quality, effective, fit for intended use, and compliant with relevant regulations. The training will also cover the key principles and practices presented in the guide for the design, development, operation, and use of AI.
NOTE: It is recommended that GAMP AI training attendees have already taken the GAMP T45 or T07 training course.
What You Will Learn
- International regulatory requirements for GxP AI-enabled computerized systems
- Overview and business benefits of the GAMP® AI Guide
- Lifecycle approach for AI-enabled computerized systems
- Scalable specification and risk-based verification strategies
- Quality Risk Management as applied to AI subsystems
- Roles of regulated companies and AI service providers
- AI system development aligned with GAMP® principles
- Pragmatic practices for cost-effective compliance
- Current and emerging topics in AI
- Best practices for effective use of the GAMP® AI Guide
Resources and Activities
- Pre-Course Work Materials
- This course is developed by leaders and authors of the GAMP® AI Guide and members of the ISPE GAMP® Community of Practice, Software Automation and Artificial Intelligence SIG.
- Interactive Exercises
- Learning Assessments
- ISPE GAMP® Guide: Artificial Intelligence
Course Modules
The following topics will be covered in this 2 day course, though module order, depth, or specific inclusions may vary as the curriculum continues to mature:
- Course & AI Guide Overview
- Key AI Concepts
- Life Cycle & CSV for AI-enabled Systems
- AI Life Cycle Overview
- Concept Phase
- Quality Risk Management (QRM) for AI
- Supplier Interfaces
- Project Phase
- People and Culture
- Operation & Retirement Phases
- Value and Importance of Data
- Emerging Topics in AI Technology and Regulation
Final module selection may be updated to reflect the most current industry practices and regulatory priorities.
Who Should Attend
This course is designed for professionals looking to build a strong foundation in compliance and regulatory considerations for AI-enabled computerized systems, including:
- Senior and Functional Management – decision-makers overseeing AI strategy, investment, and risk
- Quality Unit / Quality Assurance / Compliance – responsible for GxP compliance, data integrity, and inspection readiness
- IT and Digital / Automation Teams/cybersecurity professionals – designing, implementing, and maintaining AI-enabled systems
- Data Science and AI/ML Teams – developing and maintaining AI models used in GxP applications
- Research, Development, and Manufacturing Operations – users and process owners of AI-enabled systems
- Internal and External Suppliers and Service Providers – providing AI solutions, platforms, or services
Additional Course Details
The course provides an overview of overarching principles regarding AI-enabled systems compliance, including a scalable and efficient system lifecycle, Quality Risk Management (QRM), supplier assessment, and the selection of appropriate specification and verification activities. The guidance is focused on “what” companies need to consider but does not aim to cover detailed and highly technical aspects of data and model engineering.
Learning Objectives:
- Explain the evolving regulatory requirements and expectations for AI-enabled computerized systems
- Apply GAMP® AI principles to specific systems and cases
- Describe the GAMP® approach to AI-enabled computerized systems compliance
Community of Practice (COP)
This training course is of particular interest to existing and future members of the following ISPE GAMP® Community Communities of Practice (COP).
Training Notifications
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This course may also be delivered as Custom Training for your team.
Daily Schedule and Pricing
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Boston, MA United States
In Person24 - 25 Jun 2026Daily Schedule at a Glance
Training course times are listed in Central European Time. Find your personal viewing time on the World Clock.
0830 – 0845 Login 0845 - 0900 Introductions 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion Registration Fee
*ISPE Membership is required for these registration rates.
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Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.
Training Course Venue
The Westin Copley Place
10 Huntington Avenue
Boston MA 02116, USA
Tel: +1 617-262-9600Cancellations/Refunds
Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.