AI in GMP: What the FDA Is Already Expecting - Before You Ask
FDA already expects GMP compliance for AI systems. Learn how existing validation, data integrity, and oversight rules apply—before regulators come calling.
Instructor
Dr. Ginette Collazo
Industrial-Organizational Psychologist & GMP Human Performance Expert
What You'll Learn
About the event
About this event
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
Curriculum
Requirements
- Working in FDA-regulated industries (pharma, biotech, medical device)
- Familiarity with GMP regulations and quality systems
- Applicable to quality assurance, regulatory affairs, validation, and operations professionals
Who Should Attend
This training is designed for organizations operating in GMP-regulated environments that are implementing, evaluating, or considering AI-enabled technologies within their operations and quality systems. A must-attend for professionals responsible for quality, compliance, digital transformation, validation, and operational excellence in regulated industries, including: Quality Assurance Departments, Regulatory Affairs Departments, Validation and CSV Teams, Compliance Managers and Directors, Manufacturing Departments, Operations Departments, IT and Digital Transformation Professionals, CAPA and Deviation Management Teams, Data Integrity Specialists, Risk Management Professionals, Internal Auditors and Inspection Readiness Teams, and Executive Leadership Evaluating AI Adoption.
Areas Covered
Meet Your Instructor
Dr. Ginette Collazo
Industrial-Organizational Psychologist & GMP Human Performance Expert
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. As Founder and CEO of Human Error Solutions—recognized by Manufacturing Outlook magazine in 2023 as one of the top industrial service providers—she leads 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, and has been featured in Manufacturing Outlook, ABC, NBC, Fox, and CBS for her contributions to manufacturing excellence and compliance innovation. She is also the host of The Power of Why Podcast, exploring workplace behavior, leadership, critical thinking, and emerging technologies.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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