Factorytalk is pleased to participate in ISPE Malaysia 2026, bringing our expertise in GxP digitalisation, manufacturing systems, validation, and regulatory compliance to the industry community.
As part of the event programme, David Margetts, Group Executive Director at Factorytalk, will present a one-hour session exploring how artificial intelligence (AI) can be implemented responsibly and effectively within regulated manufacturing operations.
AI has the potential to transform manufacturing by supporting faster decision-making, improving operational efficiency, identifying process risks, and enabling teams to make better use of manufacturing data.
However, implementing AI within a GxP environment presents additional challenges. Manufacturers must consider regulatory expectations, data integrity, system validation, intended use, model performance, human oversight, and the ongoing management of AI-enabled solutions throughout their lifecycle.
In this session, David will provide a practical overview of the current AI landscape for life sciences manufacturing. He will discuss how organisations can identify appropriate AI use cases, evaluate associated risks, and apply a structured approach to validation and governance.
Session Agenda
1. Background to AI in GxP manufacturing
Understand the development of AI technologies and how they are beginning to support manufacturing operations in regulated life sciences environments.
3. Best practices for validating AI in GxP use cases
Learn how guidance and best practices from the GAMP AI Community of Practice can help organisations apply a risk-based approach to AI validation, governance, and lifecycle management.
2. Regulatory developments and AI enablers
Explore the evolving regulatory landscape and the technical, organisational, and data foundations required to implement AI responsibly.
4. Practical examples and industry case studies
Discover examples of how AI can be applied to manufacturing operations and the key lessons organisations should consider when progressing from early exploration to practical implementation.
What you will learn
By attending this session, participants will gain a clearer understanding of:
- The role of AI in modern GxP manufacturing operations
- Current regulatory considerations affecting AI adoption
- The key enablers required for successful AI implementation
- Risk-based approaches to validating AI-enabled systems
- Practical AI use cases and lessons from the life sciences industry
- How to balance innovation, compliance, and human oversight
Explore AI Opportunities for Your Manufacturing Operations
Are you considering how AI could support your GxP manufacturing operations? Speak with Factorytalk’s experts to discuss potential use cases, regulatory and validation considerations, and a practical approach to implementing AI responsibly within your organisation.
