Agentic AI Systems in GMP Environments – Foundations
$80.00 US
Module 1 introduces the foundations of ‘agentic’ artificial intelligence (Agentic AI) in GMP-regulated environments.
Course duration: Allow 3 to 4 hours.
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Description
Module 1 introduces the foundations of ‘agentic’ artificial intelligence (Agentic AI) in GMP-regulated environments. It provides an overview of Agentic AI system designs and how they differ from traditional automation, along with key Artificial Intelligence (AI) system terms and definitions.
How it fits into the 5-Module GMP Training Series:
Module 1 establishes a foundation for understanding Agentic AI systems, including key concepts for defining, classifying, and governing these systems, and understanding system-specific behavioural risk in a GMP environment.
Module 1 is an important primer for further learning in Modules 2 through 5.
Benefits of Completing Module 1
This module will help you understand the behavioural risks associated with giving AI systems greater autonomy. It will help you distinguish between different types of AI-based systems using appropriate regulatory and compliance terminology.
This knowledge can support more effective communication and collaboration with team members, IT personnel, system developers, Quality teams, senior management, organisational stakeholders, and auditors or inspectors throughout the system lifecycle.
Topics covered in this module include:
- Agentic AI system terms and definitions
- Agentic AI system characteristics and classifications
- How agency – not intelligence – changes risk
- How to distinguish Agentic AI systems from traditional tools and workflows
Who can benefit from Module 1:
- 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
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