Why take this course?
OOS results are rarely isolated laboratory events. They test how assumptions are made, how evidence is interpreted, and whether the quality system can respond when a result falls outside expectations. In many investigations, retesting starts early, possible causes are narrowed too soon, and the review structure masks weak scientific reasoning. Those weaknesses matter because FDA scrutiny is centered not only on whether an investigation was completed, but on how each decision was made.
This program focuses on the investigation pathway from the initial result through cause evaluation and final documentation. It examines how laboratory findings, process signals, and quality indicators should be weighed, and where overlooked inconsistencies or undocumented assumptions begin to weaken the credibility of the outcome. Attention is placed on recognizing when an inquiry should remain limited and when it needs to move beyond the laboratory.
Key Areas Covered
Carolyn Troiano
Carolyn Troiano has more than 45 years of experience in computer system validation across pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She has advised companies on FDA compliance, CSV, and large-scale IT implementations, and participated in the FDA/Industry Partnership that developed 21 CFR Part 11 for electronic records and electronic signatures.
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