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Course Fee

$1650.00 Regular Registration

$1450.00 Early Bird Pricing (Register 30 Days in Advance)

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Future Live Stream Sessions (click to register)

Handling and Investigating OOS Results Course Description

Out-of-Specification (OOS) results remain one of the most frequently cited areas during regulatory inspections and continue to present significant challenges for pharmaceutical and biopharmaceutical organizations. Effective management of OOS results requires a scientifically sound, well-documented, and compliant investigation process that identifies root causes, protects product quality, and supports patient safety. Failure to properly investigate OOS results can lead to regulatory observations, product recalls, delayed product releases, and increased compliance risks.



This course provides a practical and comprehensive approach to handling OOS results throughout the investigation lifecycle. Participants will learn how to recognize OOS events, conduct laboratory and manufacturing investigations, apply root cause analysis tools, and develop appropriate corrective and preventive actions (CAPAs). The course also covers regulatory expectations, documentation practices, SOP development, data integrity considerations, and real-world case studies that illustrate common investigation challenges and inspection findings. Through interactive discussions and examples, attendees will gain the knowledge and tools needed to conduct effective, defensible, and inspection-ready OOS investigations.

Who Should Attend This Handling and Investigating OOS Results Course?

This 10-hour course is designed for pharmaceutical and biopharmaceutical professionals involved in laboratory testing, quality oversight, and product release decisions. It is particularly beneficial for analytical scientists, laboratory supervisors, quality assurance personnel, quality control managers, manufacturing investigators, compliance professionals, auditors, and regulatory affairs staff responsible for managing, reviewing, approving, or investigating Out-of-Specification (OOS) results.

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  • Learning Objectives

    Upon completion of this course, participants will be able to:

    • Explain regulatory expectations and scientific principles governing OOS investigations. 
    • Differentiate OOS, OOT, atypical, and aberrant analytical results accurately. 
    • Develop systematic investigation plans using risk-based decision-making approaches. 
    • Identify laboratory and manufacturing causes contributing to OOS findings. 
    • Establish compliant SOPs and documentation supporting effective investigations. 
    • Evaluate case studies to determine root causes and appropriate CAPAs.

  • Agenda

    Section 1: Introduction and Principles of OOS Investigations

    • Definition of OOS, OOT (Out-of-Trend), atypical, and aberrant results 
    • Regulatory expectations from FDA, ICH, MHRA, and PIC/S 
    • Scientific principles and quality culture behind OOS investigations 
    • Roles and responsibilities of analysts, supervisors, QA, and laboratory management 

    Section 2: Recognizing OOS Results and Developing an Investigation Plan

    • Identifying potential OOS results and immediate response requirements 
    • Conducting laboratory investigations and evaluating potential laboratory errors 
    • Structured root cause analysis techniques and investigation tools 
    • Expanding investigations into manufacturing, sampling, testing, and material-related causes 

    Section 3: Establishing SOPs and Supporting Documentation

    • Developing effective OOS investigation procedures and decision trees 
    • Documentation requirements, data integrity considerations, and investigation reports 
    • Retesting, resampling, invalidation criteria, and scientifically justified conclusions 
    • CAPA development, effectiveness checks, and trending of OOS events 

    Section 4: Case Studies, Workshops, and Discussion Sessions

    • Laboratory error case studies (sample preparation, calculations, instrument issues) 
    • Manufacturing-related OOS investigations and product impact assessments 
    • Regulatory observations, warning letters, and common inspection findings 
    • Interactive group exercises on investigation strategy, root cause determination, and CAPA development 

    Optional Workshop Exercises

    • OOS vs. OOT determination exercise 
    • Investigation report review and critique 
    • Root cause analysis using Fishbone and 5-Why methodologies 
    • Mock FDA inspection interview on OOS investigations

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Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.