OOS Investigations: Decision-Making in Practice and FDA Expectations for 2026
Learn how to interpret OOS results, recognize signals, and align investigation decisions with current FDA expectations under 21 CFR Part 211.
Instructor
Meredith Crabtree
GMP Quality Consultant & Validation Specialist
What You'll Learn
About the event
OOS results are rarely just laboratory events. They test how decisions are made, how information is interpreted, and how well quality systems respond when something does not go as expected.
In many organizations, the initial response to an out-of-specification result follows a familiar path: retesting begins, assumptions are made early, and conclusions are shaped before the full picture is understood. Regulatory expectations in this area continue to evolve. Inspectors are no longer focused only on whether an investigation was completed, but on how decisions were made at each step, how scientific reasoning was applied, and whether the outcome reflects a clear and consistent approach.
This session takes a closer look at how OOS investigations unfold in practice: from the moment a result is identified to the way conclusions are formed and documented.
Code: FDB1414
Curriculum
Requirements
- Quality Assurance, QC, or Laboratory professionals in regulated industries
- Applicable to investigators, CAPA coordinators, site heads, and directors of quality
Meet Your Instructor
Meredith Crabtree
GMP Quality Consultant & Validation Specialist
Meredith Crabtree has over 30 years' experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting and specializes in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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