OOS and OOT Investigations Course

TalkFDA – SIGNATURE SEMINAR

Best Practices, Key Components and FDA Requirements

When an unexpected result appears, teams must decide whether it reflects a laboratory issue, process signal, or product risk—and document that determination with confidence. Across six focused sessions, this seminar organizes the investigation path from initial detection through root cause, CAPA linkage, and inspection-ready documentation.

Designed for professionals responsible for quality events, laboratory results, batch decisions, or investigation documentation within regulated manufacturing and testing environments.

Course Rating by 216 Learners

How This Session Is Structured

The seminar progresses through the natural sequence an investigation follows in practice. The first portion establishes regulatory expectations and laboratory assessment steps. The second builds from that foundation into root cause evaluation, trending analysis, and CAPA linkage, allowing participants to see how early decisions influence final documentation and batch disposition outcomes.

PORTION 1: Foundations and Regulatory Framework

FDA definitions and guidance for OOS and OOT
Differences between OOS, OOT, and OOE (Out of Expectation)
Phase I vs Phase II Investigations
Laboratory investigation steps and best practices
Assigning preliminary causes and assessing lab error
Deviation and non-conformance documentation
Real-world OOS case studies
Data integrity risks in OOS handling

PORTION 2: Root Cause, CAPA, and Regulatory Expectations

Conducting effective root cause analysis
CAPA development and effectiveness checks
Linkage to batch disposition decisions
Statistical evaluation and OOT trending
Handling repeat results and retesting/averaging
Documentation standards for FDA inspection readiness
Responding to 483s and regulatory expectations for OOS/OOT

Course Director

Meredith Crabtree

Meredith Crabtree brings more than three decades of regulated industry experience across laboratory operations, manufacturing, packaging, and distribution environments. Through MLKC Consulting, she supports organizations with inspection readiness, recall support, and regulatory assessments. Her background in quality systems and investigations allows her to guide participants through the practical decisions required when OOS or OOT results emerge.

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 course is delivered through TalkFDA
Access is granted shortly after purchase so you can begin without delay
Course 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.

SEM1411

Featured Upcoming Courses

🏠︎