AI in GMP: What the FDA Is Already Expecting - Before You Ask

Artificial Intelligence (AI) is rapidly becoming part of daily operations in GMP-regulated industries, from automated documentation reviews and predictive analytics to deviation investigations and training systems. While many organizations are still exploring how to implement AI effectively, the FDA is already expecting companies to apply existing GMP principles to these technologies—even before formal AI-specific regulations are fully established. This webinar examines the current FDA expectations surrounding AI use in regulated environments and explains how organizations can proactively prepare their quality systems for inspection readiness. Participants will learn how FDA expectations for validation, data integrity, risk management, supplier oversight, and human accountability already apply to AI-enabled systems. The session will provide practical guidance on how to responsibly implement AI within GMP operations while maintaining compliance, transparency, and quality oversight. Attendees will also explore common compliance gaps organizations may overlook when deploying AI tools across quality and manufacturing systems. By understanding what regulators already expect, organizations can avoid costly mistakes, strengthen governance practices, and build sustainable AI strategies aligned with GMP requirements. WHY YOU SHOULD ATTEND Many organizations are adopting AI technologies faster than they are developing governance and compliance strategies to support them. Although FDA guidance on AI continues to evolve, inspectors already expect companies to demonstrate control, oversight, validation, and risk management for any system impacting product quality or patient safety. This webinar will help attendees understand how existing GMP expectations apply to AI systems and what organizations should be doing now to avoid compliance risks. KEY HIGHLIGHTS • Regulatory Insight: Understand current FDA expectations for AI implementation within GMP-regulated operations. • Inspection Readiness: Learn what inspectors may look for regarding AI governance, validation, and oversight. • Risk Mitigation: Discover practical methods to manage AI-related risks including data integrity, bias, cybersecurity, and automated decision-making. • Practical Compliance: Gain actionable strategies for integrating AI into quality systems while maintaining GMP compliance. By attending this session, participants will gain the knowledge needed to confidently navigate AI adoption while protecting compliance, product quality, and operational integrity. TOPIC BACKGROUND Artificial Intelligence is transforming regulated industries at a rapid pace, creating opportunities for greater efficiency, automation, and predictive capabilities. However, many organizations mistakenly assume they can wait for formal AI regulations before implementing governance controls. In reality, the FDA already expects companies to apply existing GMP requirements—including validation, risk management, documentation, and oversight—to AI-enabled systems. As AI adoption expands across quality systems, manufacturing operations, training platforms, and data analysis tools, organizations must understand how to maintain compliance while leveraging innovation. This webinar provides practical guidance on aligning AI initiatives with current FDA expectations and building sustainable compliance strategies. Code: FDB1306