Good Laboratory Practices for Nonclinical Safety Studies
Comprehensive online GLP training aligned with Health Canada requirements, OECD Principles of GLP, and international standards — trusted by Canadian pharmaceutical, biotechnology, and chemical professionals. Self‑paced. 21 CFR Part 11 compliant certificates. Inspection‑ready training records.
5+ GLP Courses | 21 CFR Part 11 Compliant Certs | 3+ Regulatory Frameworks | OECD & Health Canada Aligned
Regulatory Context
GLP Compliance in Canada: Health Canada, OECD & International Standards
Canada has a well‑established regulatory framework for Good Laboratory Practice (GLP) that is closely harmonised with international standards through the Organisation for Economic Co‑operation and Development (OECD). Health Canada requires that non‑clinical safety studies submitted in support of drug applications and submissions be conducted in accordance with GLP principles.
Key Regulatory Frameworks:
| Regulatory Authority | Framework | Application |
| Health Canada | Food and Drug Regulations | Non‑clinical safety data for drug submissions |
| Health Canada | GLP Policy Directive | Sponsors submitting non‑clinical data in Clinical Trial Applications |
| OECD | OECD Principles of GLP (as revised in 1997) | Mutual Acceptance of Data (MAD) |
| Standards Council of Canada (SCC) | GLP Compliance Monitoring Authority | OECD‑recognised monitoring body |
Key Requirements:
- Studies that are considered to be core battery or pivotal as per ICH guidelines, Health Canada guidelines, or other international guidelines should be conducted under GLP conditions
- Health Canada requires GLP recognition for both domestic and foreign sites
- Canadian sites are expected to provide proof of inspection by the Standards Council of Canada
- Certain non‑clinical studies may not need to adhere to GLP depending on the importance of the studies and whether any claims are made based on such studies
Health Canada’s membership in the OECD means that data generated in accordance with OECD GLP principles is accepted through the Mutual Acceptance of Data (MAD) system, avoiding duplicative testing and reducing costs for industry.
Our Courses
GLP Training Courses — Health Canada & OECD Aligned
All courses are self‑paced, available online, and include 21 CFR Part 11 compliant certificates with verifiable IDs — accepted as documented training records during Health Canada and other regulatory inspections.
Most Popular for Canadian GLP Professionals
Good Laboratory Practices (OECD Focused)
Price: $149.00
This comprehensive training program offers an in‑depth examination of the OECD Principles of Good Laboratory Practice (GLP), as revised in 1997. Tailored for professionals in the pharmaceutical, chemical, and biotechnology sectors, the curriculum addresses the complete range of GLP requirements, including organizational responsibilities, quality assurance, study conduct, data integrity, and archival management.
The program equips participants with practical knowledge of how GLP facilitates the production of reliable, reproducible, and internationally recognized non‑clinical safety data, thereby supporting regulatory compliance, safeguarding human health, and enabling the Mutual Acceptance of Data (MAD) in global markets.
International Regulatory References:
- OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 1: OECD Principles on Good Laboratory Practice (as revised in 1997) – ENV/MC/CHEM (98)17
- OECD Council Act C(81)30(Final): Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals
- OECD Council Act‑Recommendation C(89)87(Final): Decision‑Recommendation of the Council on Compliance with Good Laboratory Practice
- OECD Council Act C(97)114/Final: Decision of the Council concerning the Adherence of Non‑Member Countries
Target Audience:
- Laboratory Technicians and Study Personnel
- Study Directors and Principal Investigators
- Quality Assurance (QA) Professionals
- Test Facility and Test Site Management
- Regulatory Affairs Specialists
- Sponsors
- New Employees in pharmaceutical, pesticide, chemical, and biotechnology industries
Enroll in Good Laboratory Practices (OECD Focused)
OECD Good Laboratory Practice (GLP) Training | GxP Trainings
GLP Internal Auditor Certification (OECD Focused)
Price: $599.00
This 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 the OECD Principles of Good Laboratory Practice (as revised in 1997). The program integrates GLP requirements for single‑site and multi‑site studies with internal auditing practices based on ISO 19011.
Operational areas covered:
- Test Facility Organisation and Personnel – test facility management responsibilities, Study Director responsibilities, Principal Investigator responsibilities (for multi‑site studies), study personnel responsibilities
- Quality Assurance Programme – independence from study conduct, study‑based inspections, facility‑based inspections, process‑based inspections, QA statement in final report
- Facilities – general requirements, test system facilities, facilities for handling test and reference items, archive facilities, waste disposal
- Apparatus, Material and Reagents – design, calibration, maintenance, labelling, expiry date management
- Test Systems – physical/chemical systems, biological systems (animals, plants), acclimatisation, isolation, health evaluation
- Test and Reference Items – receipt, handling, sampling, storage, characterisation, stability, homogeneity, batch retention
- Standard Operating Procedures – availability, approval, deviations, historical file
- Performance of the Study – study plan, study plan amendments, study plan deviations, conduct of the study, raw data recording, data changes, audit trails
- Reporting of Study Results – final report content, QA statement, Study Director signature, amendments
- Storage and Retention of Records and Materials – archives, retention periods, indexing, access control
- Multi‑Site Study Management – Principal Investigator role, communication, master schedule, study plan for multi‑site studies, delegation of phases
- 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
Target Audience:
- Quality Assurance Personnel
- Internal Auditors (both existing and prospective)
- Study Directors
- Testing Facility Management
- Archivists
- Laboratory Supervisors
- Sponsor Representatives
Prerequisites:
- 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
Enroll in GLP Internal Auditor Certification (OECD Focused)
OECD GLP Internal Auditor Certification Course | GxP Trainings
Additional GLP Training Courses
GLP Internal Auditor Certification (FDA Focused)
Price: $599.00
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.
Operational areas covered:
- 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
Target Audience:
- Quality Assurance Unit Personnel
- Internal Auditors
- Study Directors
- Testing Facility Management
- Archivists
- Laboratory Supervisors
- Sponsor Representatives
Prerequisites:
- 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
Enroll in GLP Internal Auditor Certification (FDA Focused)
GLP Internal Certified Auditor (FDA Focused) I GLP Training
ISO 19011:2026 – Auditing Management Systems
Price: $199.00
This comprehensive training program is designed to provide individuals with a thorough understanding of ISO 19011:2026, “Guidelines for Auditing Management Systems.” The program covers all aspects of the standard, including the principles of auditing, managing an audit programme, conducting management system audits, and evaluating the competence of individuals involved in the audit process.
The program addresses both traditional on‑site auditing methods and remote auditing methods, including guidance from ISO/IEC TS 17012. It covers first‑party (internal) audits, second‑party (external provider) audits, and provides useful guidance for external audits conducted for purposes other than third‑party management system certification.
Target Audience:
- Internal Auditors
- Audit Programme Managers
- Quality Managers and Quality Professionals
- Management System Practitioners
- Second‑Party Auditors
- Consultants
- Individuals Preparing for Auditor Certification
- Top Management and Leaders
Enroll in ISO 19011:2026 – Auditing Management Systems
ISO 19011:2026 Auditor Training Course Online | GxP Trainings
Who Needs GLP Training in Canada?
GLP training is essential for all personnel involved in the generation, management, and regulatory submission of non‑clinical safety data in Canada.
Laboratory Personnel
- Laboratory Technicians and Study Personnel
- Study Directors and Principal Investigators
- Analytical Chemists and Biologists
Quality & Compliance
- Quality Assurance (QA) Professionals
- Internal Auditors
- Regulatory Affairs Specialists
- Compliance Officers
Management
- Test Facility Management
- Test Site Management
- Laboratory Supervisors
Sponsors & Contract Research Organisations
- Sponsors commissioning non‑clinical studies
- Contract Research Organisation (CRO) personnel
- Archivists and Data Managers
GLP Inspections, Compliance Risk & Training Records
What Happens When GLP Training Falls Short
Health Canada, through the Standards Council of Canada (SCC) as the GLP Compliance Monitoring Authority, conducts inspections of test facilities to verify adherence to GLP principles. Inspection findings can have serious consequences:
- Non‑compliance statements affecting the acceptance of study data
- Rejection of study data in regulatory submissions
- Suspension or revocation of GLP compliance status
- Legal action under the Food and Drugs Act
Common Health Canada GLP inspection observations include:
- Inadequate personnel training and documentation
- Insufficient quality assurance oversight
- Poor documentation practices and data integrity issues
- Inadequate facilities and equipment maintenance
Inspection‑Ready Training Records
Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that Health Canada and SCC inspectors accept during inspections.
- Unique verifiable certificate ID — check at gxptrainings.com/verify-certificate/
- Includes completion date, course name, and assessment score
- Downloadable PDF — upload to any QMS or LMS
- Accepted by Health Canada and SCC inspectors
- Satisfies OECD GLP and Health Canada training requirements
Why Choose GxP Trainings for GLP
| Feature | GxP Trainings |
| OECD Principles of GLP aligned | ✓ |
| Health Canada GLP Policy aligned | ✓ |
| 21 CFR Part 58 (FDA GLP) covered | ✓ |
| ISO 19011 auditing principles covered | ✓ |
| 21 CFR Part 11 compliant certificate | ✓ |
| Self‑paced — study on your schedule | ✓ |
| Instant certificate download | ✓ |
| Verifiable certificate ID | ✓ |
| Group / corporate enrollment | ✓ |
Frequently Asked Questions
Q: Is online GLP training accepted by Health Canada?
Yes. Health Canada does not mandate a specific training delivery format. What matters is that training is documented, role‑appropriate, and effective. Our 21 CFR Part 11 compliant certificates provide verifiable proof of training that Health Canada and SCC inspectors accept during inspections.
Q: What is the difference between the OECD Focused and FDA Focused GLP Internal Auditor courses?
The OECD Focused course is based on the OECD Principles of GLP (as revised in 1997), which are applicable internationally and are the basis for Health Canada’s GLP requirements. The FDA Focused course is based on 21 CFR Part 58, which is specific to FDA requirements. Both courses provide comprehensive internal auditor training.
Q: What are the prerequisites for the GLP Internal Auditor courses?
Completion of basic GLP awareness training of at least four hours or equivalent on‑the‑job experience, and at least six months of experience in a nonclinical laboratory testing facility.
Q: Do you offer group discounts for Canadian companies?
Yes. We offer corporate and group enrollment options for teams of all sizes. Contact us for a custom quote.
Q: How long do I have access to the course?
All courses include lifetime access — study at your own pace, on your own schedule.
Q: Are the certificates verifiable?
Yes. Each certificate includes a unique verifiable ID that can be checked at gxptrainings.com/verify-certificate/
Canada GLP Compliance Summary
Health Canada requires that non‑clinical safety studies submitted in support of drug applications and submissions be conducted in accordance with Good Laboratory Practice principles.
OECD Principles of GLP
The OECD Principles of Good Laboratory Practice (as revised in 1997) form the basis for GLP compliance in Canada.
Key Principles:
- Test Facility Organisation and Personnel – clear responsibilities for management, study directors, and study personnel
- Quality Assurance Programme – independent monitoring of studies and inspections
- Facilities – adequate facilities for test systems, test items, and archives
- Apparatus, Material and Reagents – proper design, calibration, and maintenance
- Test Systems – proper handling and care of biological and physical systems
- Test and Reference Items – proper receipt, handling, sampling, and storage
- Standard Operating Procedures – written procedures for all activities
- Performance of the Study – study plan, amendments, deviations, and conduct
- Reporting of Study Results – final report with QA statement
- Storage and Retention of Records – secure archives with proper retention periods
Mutual Acceptance of Data (MAD)
Canada is a participant in the OECD Mutual Acceptance of Data (MAD) system. Data generated in accordance with OECD GLP principles is accepted in other OECD member countries, avoiding duplicative testing and reducing costs for industry and governments.
All GxP Trainings courses referenced above are designed to align with OECD Principles of Good Laboratory Practice, Health Canada GLP Policy, and international GLP standards.