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Investigations Into Deviations and Out-of-Specification (OOS) Test Results in Pharmaceutical Manufacturing

Elevate your pharmaceutical quality management skills with this comprehensive course. Learn to navigate complex deviations, conduct thorough investigations, and handle OOS results with confidence.

Gain a deep understanding of US FDA and ICH regulations while mastering industry best practices. Through interactive exercises and real-world examples, you'll acquire the skills to prevent costly product recalls, protect your brand's reputation, and ensure ongoing regulatory compliance. 

Through interactive exercises and real-world examples, you'll learn how to identify and address quality issues promptly, ensuring your products meet the highest standards.

 

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Brief Overview of This Pharma Investigations Training Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

2 Days

Teaching Format

Live, Instructor-Led

Delivery Options

Private Team Training Only*

Certification of Completion

Yes

Continuing Education Units (CEUs)

1.6

* This class is only offered privately to groups of six or more. We can conduct this class virtually or at your facility. 

Upcoming Classes

Upcoming Training Classes on Pharmaceutical Deviations and OOS Investigations

SkillsLab $2195

SkillsLab $2195

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
IDP VIRTUAL DELIVERY (Eastern time - PM) 20 Oct 2026 23 Oct 2026 1:00PM - 5:00PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

What We Cover in This Investigations Into Deviations and Out-of-Specification Test Results Class

This course equips participants with the skills to effectively manage deviations, conduct thorough investigations, and handle OOS results, aligning with FDA requirements and guidance. Through interactive exercises, you'll gain practical experience applying new knowledge and skills to real-world scenarios.

Course Overview
SkillsLab Class

Regulatory Framework

  • Drug cGMP regulatory requirements overview
    1. US FDA
    2. ICH
  • Regulatory requirements: Conducting investigations
  • Pharmaceutical quality system (PQS)
  • Risk management
Exercise! ICH Q7 and 21 CFR Part 211 Crosswalk

Introduction to Deviations and OOS Test Results

  • Deviations, out-of-specification definitions, examples
  • Planned and unplanned deviations
  • OOS test results investigations
Exercise! Warning Letter

Root Cause Investigations - Part I

  • Root cause analysis process
  • Problem statements, tools
  • Data collection and stratification
Exercise! Problem Definition
Exercise! Refining the Problem

Root Cause Investigations - Part II

  • Root cause tools
  • Root cause verification
  • Testing and verification activities
Exercise! 5 Whys Tool (Option: Fishbone Tool)
Exercise! Verify the Root Cause

CAPA

  • CAPA definitions, plan
  • Sources of CAPA requirements
  • Solutions
  • Effectiveness verification
Exercise! Create, Select, and Implement Solutions
Exercise! Effectiveness Verification

FDA Inspection Readiness

  • cGMP inspection expectations
  • US FDA approach to inspecting CAPA
  • Common CAPA issues
  • Prepare for inspections: Best practices
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Identify regulatory expectations and guidance for investigations of deviations and OOS

Explain how to handle OOS test results

Explain how to investigate deviations by determining root cause

Describe how to implement remedies to solve problems

Identify corrective and preventive actions (CAPA)

Describe the expectations of an FDA inspection

Who Should Attend

Who Should Attend

  • Research and development (R&D) scientists
  • Laboratory managers
  • Manufacturing and production managers
  • Regulatory affairs personnel
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