OOS Investigations: Decision-Making in Practice and FDA Expectations

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LIVE WEBINAR

OOS Investigations: Decision-Making in Practice and FDA Expectations for 2026

How to interpret results, recognize signals, and align with current FDA expectations

OOS results require disciplined decisions from the first assessment, because early interpretation often determines whether the investigation remains credible and complete. This session structures OOS evaluation pathways, helping teams interpret results, expand inquiries appropriately, and document conclusions with consistent scientific reasoning.

Designed for professionals responsible for result assessment, investigation oversight, and quality decisions that must withstand regulatory review.

How This Session Is Structured

The session follows the investigation sequence from initial result review through cause evaluation and final documentation. It distinguishes how laboratory findings, process signals, and broader quality indicators are weighed, then clarifies when escalation is warranted and how current FDA expectations shape each decision point.

Key Areas Covered

Initial assessment of OOS results and first-step decision pathways
Recognizing trends, signals, and inconsistencies during review
Distinguishing laboratory error from process-related causes
Determining when investigations should expand beyond the laboratory
Applying scientific reasoning to interim and final conclusions
Documenting investigation logic under 21 CFR Part 211 expectations
Aligning OOS handling with current FDA guidance principles

Course Director

Meredith Crabtree

Meredith Crabtree brings over 30 years of experience across laboratory, manufacturing, packaging, labeling, and distribution operations in regulated industries. Her work in regulatory assessments, third-party inspections, consent decree support, and quality training positions her to address how OOS investigations are evaluated in practice and how decision-making must be documented under current FDA expectations.

What Happens After You Reserve Your Seat

Your registration is managed by our events team to ensure a coordinated and seamless experience.

A confirmation email outlines onboarding details and next steps
Access credentials are shared in advance so you are prepared before the session
Handouts (where applicable) are provided ahead of time
The training is delivered live via Webex with interactive participation and Q&A
Certificates of completion are issued following the session
For live + recording access, post-session availability is provided through TalkFDA
Event support remains available for any access or logistics assistance

Access is provided in a structured and professionally supported format.

A confirmation email outlines onboarding and next steps
The complete session recording is delivered through TalkFDA
Access is granted shortly after purchase so you can begin without delay
Recording includes the full presentation and instructor-led discussion
Certificates of completion are issued upon course completion
Support remains available for any technical or access assistance

For Teams Seeking Deeper Implementation Support

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.

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