SCOPE

This self‑study training program defines the complete knowledge and performance requirements for personnel within a nonclinical laboratory testing facility to become certified internal auditors for Good Laboratory Practice (GLP) as prescribed in 21 CFR Part 58. The program integrates GLP requirements for nonclinical laboratory studies with internal auditing practices based on ISO 19011.

The participant learns both what GLP requires and how to plan, execute, report, and close internal audits of those requirements.

Operational areas covered by this program include:

• Facilities – animal care areas, animal supply areas, test and control article handling areas, laboratory operation areas, specimen and data storage facilities.
• Equipment – design, maintenance, calibration, and inspection requirements.
• Testing facility operations – standard operating procedures, reagents and solutions, animal care.
• Test and control articles – characterization, handling, and mixtures with carriers.
• Protocol and conduct of studies – protocol approval, changes, and study conduct.
• Records and reports – final reporting, storage and retrieval, retention requirements.
• Quality assurance unit – responsibilities, inspections, reporting, independence from study conduct.
• Personnel and management – training, job descriptions, study director responsibilities, management obligations.
• Auditing practices – audit programme management, audit planning, checklist design, evidence collection, sampling, working papers, non‑conformity classification, report writing, management notification, CAPA tracking, effectiveness verification, and audit closure.

The program is designed for internal auditing only and does not qualify individuals for FDA or other regulatory inspections.

OBJECTIVES

Upon completion of this self‑study program, the participant will be able to perform the following tasks.

• Interpret and apply all 21 CFR Part 58 GLP requirements to nonclinical laboratory operations.
• Understand and apply the seven quality management principles in the context of GLP.
• Plan, manage, and execute internal audits in full accordance with auditing guidelines.
• Develop audit checklists, sampling plans, and audit protocols tailored to GLP risks.
• Collect objective evidence through interviews, observation, and document review.
• Identify and classify non‑conformities as major, minor, or observation with clear justification.
• Write non‑conformity reports that are factual, complete, and actionable.
• Prepare and distribute audit reports to appropriate management levels.
• Notify management of critical findings using escalation procedures.
• Track CAPA using a formal CAPA tracking log with status codes.
• Verify effectiveness of corrective and preventive actions.
• Close an audit properly with closure memo and management acknowledgment.
• Contribute audit results to management review and continual improvement.

TARGET AUDIENCE

This program is specifically designed for personnel working in nonclinical laboratory testing facilities that conduct studies in support of FDA applications for research or marketing permits. Typical roles include the following.

• Quality Assurance Unit Personnel – responsible for monitoring studies, conducting inspections, and assuring compliance with GLP regulations.
• Internal Auditors – both existing and prospective, who need formal training on GLP‑specific requirements and audit techniques.
• Study Directors – have overall responsibility for the technical conduct of studies and need to understand how their studies will be audited.
• Testing Facility Management – responsible for designating study directors, assuring resources, and ensuring compliance.
• Archivists – manage storage and retrieval of raw data, specimens, protocols, and final reports.
• Laboratory Supervisors – oversee animal care, test article handling, or analytical procedures.
• Sponsor Representatives – initiate and support nonclinical laboratory studies and need to understand testing facility compliance.

Prerequisites for enrolment:

• Completion of basic GLP awareness training of at least four hours or equivalent on‑the‑job experience.
• At least six months of experience in a nonclinical laboratory testing facility.
• Basic computer skills using Excel and Word.

CERTIFICATION 

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.