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Join us for an immersive 2-day event focused on leveraging and validating Artificial Intelligence (AI) to drive innovation and efficiency within the GxP environment. "Harness the Power of AI in GxP" will feature a series of case study driven sessions that reveal the latest developments in AI applications, process optimization, validation, and compliance within regulated life sciences industries. Whether your goal is to validate AI for regulatory compliance, streamline manufacturing, or ensure data integrity, this conference delivers actionable insights to keep you at the forefront of technology and regulation.
Session Highlights: Dive into Real-World Use Cases and Compliance Strategies
Understanding Regulatory Frameworks for AI in GxP
Explore essential regulatory considerations, including FDA guidance on AI, Part 11 compliance for electronic records, and the latest on data integrity standards. Industry experts will provide insights into ISPE® AI quality and compliance initiative and discuss how to ensure alignment with global standards.
· Navigating FDA guidance on AI/ML in life sciences
· Part 11 compliance: Ensuring secure and accurate electronic records
· ISPE® AI Quality and Compliance Initiative: An in-depth overview
· Addressing data integrity challenges in AI-driven processes
· Managing regulatory expectations across global markets
· Ensuring transparency and accountability in AI validation processes
Case Studies and Validation of AI in GxP
Learn from specific use cases demonstrating how AI is transforming GxP processes. Topics include optimizing manufacturing workflows, enhancing validation accuracy, and applying predictive analytics in quality control. Sessions will also cover best practices for validating AI processes to meet compliance requirements, ensuring safe and effective AI implementation in regulated environments.
· AI-driven automation in GMP environments: Practical examples
· Optimizing quality control and data integrity through AI
· Best practices for validating AI algorithms and models
· Leveraging predictive analytics for preventive maintenance
· Case study: AI applications in continuous process improvement
· Enhancing validation speed and accuracy with AI
· Real-world applications of AI in manufacturing and supply chain
