Discover how existing GMP regulations already apply to AI-enabled systems and what your organization must do now to stay inspection-ready — before formal AI-specific rules arrive.
Includes live access & recording
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.
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.
By the end of this session, participants will be equipped to navigate AI adoption within GMP-regulated environments with confidence and compliance.
Understand how current GMP regulations already apply to AI-enabled systems.
Identify FDA expectations regarding AI governance and oversight.
Learn validation considerations for AI-driven applications.
Understand data integrity risks associated with AI technologies.
Apply risk-based approaches for AI implementation within quality systems.
Evaluate the role of human oversight in AI-assisted decision-making.
Develop strategies for documenting and monitoring AI systems.
Prepare organizations for regulatory inspections involving AI technologies.
Four focused areas that will transform how your organization approaches AI compliance in GMP environments.
Understand current FDA expectations for AI implementation within GMP-regulated operations and how existing rules already apply.
Learn what inspectors may look for regarding AI governance, validation, and oversight during regulatory visits.
Discover practical methods to manage AI-related risks including data integrity, bias, cybersecurity, and automated decision-making.
Gain actionable strategies for integrating AI into quality systems while maintaining GMP compliance and operational integrity.
A comprehensive deep-dive across 13 critical areas of AI compliance in GMP-regulated environments.
Organizations operating in GMP-regulated environments implementing, evaluating, or considering AI-enabled technologies within their operations and quality systems.
Quality Assurance Departments
Regulatory Affairs Departments
Validation and CSV Teams
Compliance Managers and Directors
Manufacturing Departments
Operations Departments
IT & Digital Transformation Professionals
CAPA & Deviation Management Teams
Data Integrity Specialists
Risk Management Professionals
Internal Auditors & Inspection Readiness Teams
Executive Leadership Evaluating AI Adoption
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.
Dr. Ginette Collazo brings 20+ years of experience in Industrial-Organizational Psychology specializing in GMP-regulated industries and human performance systems. She is an internationally recognized expert in quality systems, root cause analysis, compliance excellence, and operational performance.
Founder and CEO of Human Error Solutions, a globally recognized consulting and training organization supporting regulated industries, Dr. Collazo is an experienced speaker and educator on GMP compliance, human performance, AI governance, and quality culture. She has been featured in Manufacturing Outlook, ABC, NBC, Fox, and CBS for contributions to manufacturing excellence and compliance innovation.
She is the host of The Power of Why Podcast, exploring workplace behavior, leadership, critical thinking, and emerging technologies. In 2023, Human Error Solutions was recognized as one of the top industrial service providers by Manufacturing Outlook magazine.
Don't miss this critical training on navigating AI adoption within GMP environments. Secure your spot and make your quality system inspection-ready.