Agentic AI Systems in GMP-Regulated Environments – GMP Training Series

Description

The GMP training courses in this 5-module eLearning series explore key considerations for the design and use of Artificial Intelligence (AI) systems in GMP-regulated environments.
GMP = Good Manufacturing Practice 

Course Description

This GMP training series will provide an understanding of key safe-use controls, including system design strategies that support the safe use of Agentic AI systems in GMP-regulated environments. These controls and strategies should be considered when planning, implementing, and evaluating such systems.

From learning the essential AI terms and definitions to understanding the importance of a strategic scope document that includes guardrails and escalation boundaries, these self-paced eLearning courses will provide you with a robust foundation for discussing Agentic AI system use with your GMP colleagues and developers, all without needing to understand coding and mathematics.

What’s included in the eLearning Series (Agentic AI Training Topics) 

The following 5 individual eLearning modules are included in this Agentic AI Systems/GMP training series. While you can purchase these modules individually, you will benefit most from completing all 5 modules in sequential order.

Agentic AI Systems in GMP Environments – Foundations (A100)

Agentic AI Systems – Decision Logic, Scope, and Safe Autonomy (A200)

Agentic AI Systems – Knowledge, Data Integrity, and Grounding (A300) – Available in October 2026

Agentic AI Systems – Oversight, Risk, and Governance (A400) – Available in November 2026

Agentic AI Systems – Applied Design and Case Study (A500) – Available in December 2026

Note: When you complete your purchase of the series, you will gain 24/7 access to Modules 1 and 2 immediately (check your emails for your log-in information). Modules 3 through 5 will be automatically uploaded to your account in the GMP Learning Management System (LMS) in the months listed above. 

Benefits of Completing this 5-Module eLearning Series

Completing the Agentic AI Systems in GMP-Regulated Environments eLearning series will help you understand the potential benefits and risks of using AI-based systems in a GMP-regulated environment. These modules provide regulatory compliance insights and behavioural controls to consider when planning, implementing, evaluating and monitoring an Agentic AI system (or Agent).

In addition to completing this training series, you will need a sound understanding of GMP compliance requirements and current regulations. As the regulatory landscape is evolving rapidly, it remains important to stay up to date with regulatory requirements and compliance expectations.

Topics covered in this 5-module training series include:

• How AI-based systems can impact quality systems and product quality
• System characteristics and design considerations
• Decision-making logic and boundaries or guardrails
• Risk management considerations for AI system designs in GMP environments
• Unique governance requirements for Agentic AI systems
• Changes to data integrity controls and system validation approaches
  • Traditional automation vs Agentic AI system validation requirements
  • Focus on AI system behaviours/behavioural risks
• Regulatory compliance insights
  • System design transparency (auditability, traceability)
  • Human accountability and controls
  • Input sources and output monitoring
  • Ensuring appropriate guardrails and authority boundaries
  • Human accountability vs AI system autonomy and authority

Who can benefit from this GMP eLearning Series:

• Quality Management Teams and other GMP industry personnel
• System and Process Owners
• GMP Compliance Team Professionals including documentation experts
• IT, Automation and Computerised Systems Professionals
• Agentic AI System Developers and System Testing Personnel
• Validation, Qualification and CSV professionals
• GMP Industry Engineers and Technical personnel
• Manufacturing, Operations and Laboratory personnel
• Managers, business owners and sponsors responsible for GMP/GxP activities
• Suppliers, Contractors, and service providers supporting regulated operations
• Regulatory Authorities, Regulatory Compliance personnel and Auditors/Inspectors