Good Laboratory Practices (GLP) Course

Lesson 1 • Core GLP Principles and Scope

Defines the fundamental principles governing GLP-compliant studies. Establishes scope boundaries for which studies and facilities must comply.

Lesson 2 • Regulatory Framework Overview

Surveys the international regulatory bodies and mutual recognition agreements governing GLP. Prepares learners to navigate multi-jurisdictional compliance expectations.

Lesson 3 • Key Definitions and Terminology

Introduces standardized GLP vocabulary used throughout all compliance activities. Precise terminology prevents misinterpretation during audits and reporting.

Lesson 1 • Quality Assurance Unit Structure

Describes the independent QA unit's mandate, staffing, and reporting lines. Establishes QA's role as an objective compliance monitor separate from study execution.

Lesson 2 • Personnel Training and Competency

Covers training program design, documentation, and competency verification for all GLP staff. Links personnel qualification to study reliability and regulatory acceptance.

Lesson 3 • Test Facility Management Obligations

Outlines management's duty to resource, authorize, and oversee GLP compliance. Connects leadership accountability to facility-wide quality outcomes.

Lesson 4 • Study Director Authority and Duties

Defines the study director as the single point of scientific control for each study. Covers decision-making authority, documentation duties, and deviation management.

Lesson 1 • Final Report Preparation

Covers required content, authorship, and sign-off procedures for GLP final reports. A complete, accurate final report is the primary deliverable of every GLP study.

Lesson 2 • Writing Effective SOPs

Teaches structured SOP authorship including format, language, and approval workflow. Well-written SOPs reduce procedural errors and support consistent execution.

Lesson 3 • Study Plan Preparation and Control

Guides learners through drafting, approving, and amending GLP study plans. The study plan is the contractual and scientific blueprint for every compliant study.

Lesson 4 • SOP Management and Change Control

Covers the lifecycle of SOPs from issuance through retirement and archiving. Change control prevents unauthorized modifications that could compromise study integrity.

Lesson 1 • Preventive and Corrective Maintenance

Teaches scheduled preventive maintenance planning and corrective maintenance documentation. Maintenance records demonstrate equipment fitness throughout the study period.

Lesson 2 • Equipment Qualification and Validation

Covers installation, operational, and performance qualification for GLP instruments. Qualified equipment produces reliable, reproducible data accepted by regulatory authorities.

Lesson 3 • Equipment Calibration Programs

Defines calibration schedules, standards traceability, and out-of-tolerance response procedures. Calibrated instruments are prerequisite to defensible quantitative study data.

Lesson 4 • Computer Systems and Automated Equipment

Addresses validation, access control, and audit trail requirements for computerized systems. Validated computer systems protect electronic raw data from unauthorized alteration.

Lesson 1 • Receipt and Characterization of Test Items

Covers documentation of test item identity, purity, stability, and receipt conditions. Accurate characterization links study results to a defined, reproducible test substance.

Lesson 2 • Reference Item Management

Covers selection, characterization, and use of reference items for study comparisons. Reference items provide the scientific benchmark against which test item effects are measured.

Lesson 3 • Disposal and Retention of Samples

Establishes retention schedules and compliant disposal procedures for test item samples. Retained samples enable retrospective verification of study results during inspections.

Lesson 4 • Preparation of Test Item Mixtures

Teaches formulation, homogeneity verification, and stability testing of test item mixtures. Mixture integrity directly affects dose accuracy and study result validity.

Lesson 1 • Documenting and Reporting Findings

Teaches how to classify, document, and communicate inspection findings to management. Clear finding reports enable timely corrective action and demonstrate QA independence.

Lesson 2 • Types of QA Inspections

Distinguishes facility inspections, process-based inspections, and study-based inspections. Understanding inspection types allows QA to allocate effort to highest-risk activities.

Lesson 3 • Corrective and Preventive Action

Guides learners through root cause analysis and CAPA plan development for GLP findings. Effective CAPA prevents recurrence and demonstrates a culture of continuous improvement.

Lesson 4 • Planning and Conducting Inspections

Covers inspection scheduling, checklist development, and objective evidence collection. Structured inspection execution produces defensible findings accepted by regulatory authorities.

Lesson 1 • Data Integrity Principles and ALCOA+

Applies the ALCOA+ framework to GLP data creation, correction, and review. Data integrity is the foundation of regulatory trust in non-clinical study results.

Lesson 2 • Archive Facility Requirements

Defines physical and environmental standards for GLP archives. A compliant archive preserves record legibility and prevents unauthorized access or loss.

Lesson 3 • Electronic Data Integrity Controls

Addresses audit trails, metadata, and access controls specific to electronic GLP records. Electronic controls must provide equivalent integrity assurance to paper-based systems.

Lesson 4 • Archiving Procedures and Indexing

Covers transfer, indexing, and retrieval procedures for study records and specimens. Systematic indexing enables rapid retrieval during regulatory inspections.

Lesson 1 • Building a Sustainable GLP Compliance Program

Integrates all GLP elements into a continuous compliance management system. A sustainable program maintains GLP status and adapts to evolving regulatory expectations.

Lesson 2 • Responding to Inspection Findings

Teaches formal response writing, commitment timelines, and follow-up verification for regulatory findings. Credible responses demonstrate corrective intent and prevent escalated enforcement.

Lesson 3 • Types of Regulatory GLP Inspections

Distinguishes routine monitoring inspections from study audits and for-cause inspections. Knowing inspection types allows facilities to prepare appropriate documentation and personnel.

Lesson 4 • Managing the Inspection Process

Guides learners through opening meetings, inspector escort, and real-time response protocols. Effective inspection management protects facility reputation and minimizes disruption.