GAMP® Fundamentals and AI/ML Basics for GxP Systems: A Practical Introduction
Complimentary
Learning Level: Intermediate/Advanced
Session Length: 1.5 hours
Join us for a dynamic 90-minute webinar designed to introduce professionals to the foundational principles of GAMP® 5 and explore its evolving role in the age of Artificial Intelligence and Machine Learning. Developed by members of the ISPE GAMP® Community of Practice, this session draws from the internationally recognized GAMP® 2-Day and 3-Day training programs and is ideal for professionals working in pharmaceutical, biotech, and medical device industries, as well as for all suppliers of products and services associated with the digitalization of processes.
Three expert instructors will guide participants through 60 minutes of focused presentations covering:
GAMP® Basic Principles: An overview of regulatory expectations for computerized systems, including US 21 CFR Parts 11 and 211 and EU Eudralex 4 with special focus on Annex 11. Learn how to apply a risk-based lifecycle approach to achieve systems that are fit for intended use and compliant with GxP requirements.
GAMP® and AI/ML: Explore how GAMP® 5 Second Edition addresses the integration of AI and machine learning technologies in regulated environments. Understand best practices for a scalable life cycle, validation, and quality risk management when implementing intelligent systems.
The session will conclude with a 30-minute interactive Q&A, offering attendees the opportunity to engage directly with instructors and clarify how GAMP® principles can be applied to their own systems and challenges.
Intended Outcome:
Participants will leave with a clear understanding of GAMP® 5 fundamentals, practical insights into AI/ML compliance for GxP systems, and actionable strategies for implementing compliant, efficient computerized systems in their organizations.
Learning Objectives
- What are the top three learning objectives or takeaways the participants will have at the end of the webinar? Please ensure your objectives correctly reflect the content that will be presented during the session.
- Understand the Core Principles of GAMP® 5
- Explore questions you should be thinking about when you are considering use of AI and ML in GXP-regulated areas
- Concepts included in Appendix D11 of GAMP® 5 related to use of AI and ML in GXP-regulated areas
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