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Good Laboratory Practices (GLP) Auditor Training

Master how to conduct effective audits for Good Laboratory Practices (GLP) by applying the principles and guidance of ISO 19011:2018. This class is designed for new auditors with a working knowledge of GLP, and it focuses on the essential skills and techniques needed to ensure the quality and integrity of non-clinical laboratory studies.

Through a series of engaging workshops and real-world audit scenarios, you'll learn to plan, execute, and follow up on GLP audits of key laboratory processes. Our expert instructors will guide you in applying the auditing principles defined by ISO 19011:2018 in the context of GLP as outlined in both 21 CFR Part 58 and OECD guidelines. This course is certified by Exemplar Global through RTP (Recognized Training Provider) and includes a comprehensive online exam to test your knowledge.

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Brief Overview of This GLP Auditing Course

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

2.5

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Good Laboratory Practices (GLP) Auditor Training Classes

SkillsLab $2195

SkillsLab $2195

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
LAP VIRTUAL DELIVERY (Eastern time - PM) 02 Nov 2026 06 Nov 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

Here's What We Cover in This Intensive GLP Auditing Course

Learn how to assess quality management system conformance with Good Laboratory Practices (GLP), specifically referencing the regulations of 21 CFR Part 58 (US Food and Drug Administration) and the OECD Principles of GLP to ensure the quality and integrity of data used for regulatory submissions.The course does this by focusing on how to plan, conduct, and follow up on audits based on the guidelines of ISO 19011:2018.

Course Overview
SkillsLab Class

GLP and Quality Management System Requirements

  • GLP regulations and guidance documents
  • Protocol and report requirements
  • Animal facilities
  • Computerized systems
  • QMS key concepts
  • Process approach to the QMS
  • Risk-based approach to the QMS
  • Auditing GLP - required documentation, records, and gathering audit evidence
  • Roadmap to regulatory compliance
Workshop! Prepare GLP Audit Evidence

Auditing Basics and ISO 19011:2018

  • QMS auditing basics
  • ISO 19011:2018 Guidelines for Auditing Management Systems
Discussion! Applying ISO 19011 Auditing Principles
Discussion! Auditor Knowledge, Skills, and Personal Behaviors

Applying a Process Approach and Risk-Based Approach to Auditing

  • Expectations for the QMS and QMS auditor
  • Process approach to auditing
  • Risk-based auditing
  • Applying the process and risk-based approach to auditing: process mapping
Discussion! Applying a Risk-Based Approach to Auditing
Workshop! Process Mapping as an Auditor Tool

Audit Planning and Preparation

  • Audit planning: preaudit activities and inputs, lead / solo responsibilities
  • Audit planning steps: initiate the audit, role of remote audits
  • Review documented information
  • Audit planning steps: create the audit plan, prepare working documents
  • Audit planning steps: preparation – verification methods, notification
Case Study! Assess Documented Information Against Audit Criteria
Discussion! Working Documents
Discussion! How Audit Evidence Answers Questions
Workshop! Prepare an Audit Plan and Working Document

Performing an Audit

  • Conducting the opening meeting
  • Audit roles
  • Communicating during the audit
  • Audit information availability and access
  • Reviewing documented information
  • Collecting and verifying information
  • Sampling
  • Interviewing auditee personnel
  • Generating audit findings
  • Determining audit conclusions
  • Conducting a closing meeting
Case Study! Interviewing Techniques Role Play
Workshop! Writing Nonconformity Reports
Case Study! Conduct an Audit
Workshop! Nonconformity Reporting
Discussion! Closing Meetings During Internal Audits

Recording and Following Up on an Audit

  • Audit reporting
  • Completing an audit
  • Following up on an audit
  • Corrective action response
Discussion! Avoid or Fix Common CAPA Problems
Workshop! Verify Corrective Action Response

End-of-Course Exam

What You Will Learn

What You Will Learn

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

Identify acceptable audit evidence for GLP requirements

Apply a process and risk-based approach to planning, conducting, and following up on an audit

Prepare for and plan a one-day audit of select GLP QMS processes, and prepare a working document with questions you’d ask

Perform an audit, including managing an audit, collecting audit evidence through document review, interviewing and observation, and documenting audit findings

Record nonconformances and concerns

Follow up on an audit, including corrective action review

Who Should Attend

Who Should Attend

This course is for quality management system professionals who are new to auditing. It's an ideal choice if you will be planning, conducting, and managing audits against Good Laboratory Practices (GLP).

  • Quality Assurance/Quality Control (QA/QC) Personnel
  • Laboratory Managers
  • Scientists and Researchers
  • Regulatory Affairs Professionals
  • Anyone responsible for GLP compliance or auditing
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