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.
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.
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.
Course Content
DAY 1Foundations 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
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
Speaker
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.Who Should Attend
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Operations Departments
- Regulatory Affairs Departments
- Compliance Departments
- Validation Departments
- Technical Services
- Auditing/Internal Auditors
- Laboratory Analysts
- CAPA Coordinators
- Site Heads and Directors of Quality
