June 10 – 11, 2025 | San Diego, California

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

What Attendees Are Saying

“The panel discussion on advancing CSA through digitization and generative AI was enlightening.  I find the workshops are useful and the speakers are approachable. I wish that some workshops in the conference can be recorded and shared with the attendees for training purposes. I would recommend this conference to my peers.  Thank you for the learning opportunity.”

– Quality Specialist, Johnson & Johnson

” Great in person Conference session with different participants from professional knowledge exchange network by great speakers about computer systems validation and software assurance.

This will have great impact on my career development and professional development, and I am so grateful to Temple university school of pharmacy for this opportunity.”

– RAQA Student/Senior Manufacturing Tech, Johnson & Johnson

Who Should Attend

This conference is ideal for professionals in the life sciences industry involved in validation, quality assurance, compliance, and AI integration within GxP settings. If you’re responsible for maintaining regulatory standards while implementing cutting-edge AI technologies, this event is tailored for you. Attendees in the following roles will especially benefit:

• Validation Engineers
• Quality Assurance Professionals
• Process Engineers
• Regulatory Affairs Specialists
• AI and Data Science Experts in Life Sciences
• Compliance Officers
• IT and Digital Transformation Leaders in GxP