September 04 - 05, 2025 | US Eastern Time: 9 AM to 2 PM | Central Europe Time: 3 PM to 8 PM
Out-of-Specification (OOS) and Out-of-Trend (OOT) results are critical indicators of process control, product quality, and data integrity. The FDA expects companies to follow rigorous and well-documented procedures for identifying, investigating, and responding to these results. This comprehensive 2-day training provides an in-depth exploration of regulatory expectations, scientific investigation best practices, and how to avoid common missteps that result in 483s or Warning Letters.
Attendees will gain a complete understanding of the life cycle of an OOS/OOT result—from initial detection to root cause analysis, interim actions, CAPA implementation, documentation, and final reporting. Using real-world examples and recent FDA enforcement cases, the course provides actionable guidance to strengthen internal processes and ensure data-driven, defensible investigations. This training is suitable for pharmaceutical, biotech, dietary supplement, and contract organizations operating under cGMP regulations.
WHY YOU SHOULD ATTEND: OOS and OOT results are among the most common—and most misunderstood—quality events in regulated manufacturing and laboratory environments. A poorly executed or incomplete investigation can lead to regulatory citations, product recalls, or even consent decrees. This course offers a hands-on, detailed roadmap for conducting compliant, science-based investigations that meet FDA expectations. Participants will learn how to properly classify OOS/OOT results, when to trigger full investigations, how to separate lab error from true quality issues, and how to document each step in a compliant and traceable manner. The course also covers trending analysis, data integrity risks, and CAPA development. Case studies will be used throughout the training to reinforce best practices and highlight common inspection findings. Whether you're in Quality, Manufacturing, or the Laboratory, this course will provide tools to improve investigation outcomes and reduce compliance risk. | WHO SHOULD ATTEND:
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DAY 1 (9 AM to 2 PM) Foundations and Regulatory Framework
| DAY 2 (9 AM to 2 PM) Root Cause, CAPA, and Regulatory Expectations
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Course Director: MEREDITH CRABTREE
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 is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings. |