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

A practical session on applying existing GMP expectations to AI-enabled systems across validation, data integrity, supplier oversight, and human accountability.

EXCLUSIVE: Get your team to
attend for just $ 390.
Individual registrations available too.

COURSE OVERVIEW & STRUCTURE

Inspectors already evaluate AI through existing GMP expectations.

Quality and compliance teams need clear criteria for evaluating AI-enabled systems before they affect GMP records, processes, or product quality. This session structures how existing GMP expectations apply to AI use across validation, documentation, supplier oversight, lifecycle management, and human review.

The session moves from current AI use in GMP environments to the quality system elements that already apply. It addresses validation, data integrity, risk assessment, change control, supplier oversight, human accountability, and inspection preparation through practical quality and manufacturing examples.

WHAT YOU’LL LEARN

Defining accountable use of AI in GMP

Current FDA expectations for AI-enabled GMP systems
Validation considerations for AI applications
Data integrity and audit trail expectations
Managing bias, hallucinations, and model drift
Supplier qualification for third-party AI tools
Change control and lifecycle management
Human review in AI-assisted outputs
AI use in CAPA, deviations, complaints, and training

WHO SHOULD ATTEND

Designed for professionals evaluating, implementing, reviewing, or approving AI use within GMP-regulated operations.

Quality Assurance

Regulatory Affairs

Validation

Manufacturing

Operations

Systems Validation

Digital Transformation

Risk Management

Compliance

Digital Transformation

FACULTY

Dr. Ginette Collazo

Dr. Ginette Collazo brings more than 20 years of experience in GMP-regulated industries, human performance systems, quality systems, root cause analysis, and compliance excellence. Her background in operational behavior, quality culture, and emerging technologies makes her well suited to address how AI adoption should be governed within GMP environments.

AFTER YOU REGISTER

Everything related to your course lives in one place.

FDB1306

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After you register your seat, our team organizes everything for you; from access to certification – “from one place”.

You receive a confirmation and your course appears instantly in your TalkFDA dashboard.
Your course page becomes your central hub where you can join the session, access materials, and manage your learning.
At the scheduled time, simply click Join Session and you’ll be connected to the live Webex session with the instructor.
After the session, the playback becomes available on the same course page so you can revisit important sections.
Complete the course and your certificate is unlocked automatically in your learning history.

For Teams Seeking Deeper Implementation Support

Customized training is also available through

TalkFDA Elite Training Labs.

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

AI in GMP: What the FDA Is

Already Expecting – Before You Ask

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