Comprehensive online GCP training aligned with Health Canada Part C, Division 5 of the Food and Drug Regulations, ICH E6(R3), and international standards — trusted by Canadian clinical research professionals, sponsors, investigators, and CROs. Self paced. 21 CFR Part 11 compliant certificates. Inspection ready training records.
Canada has a well established regulatory framework for Good Clinical Practice (GCP) that is governed by Health Canada Part C, Division 5 of the Food and Drug Regulations and aligned with the ICH E6(R3) Good Clinical Practice guideline. Health Canada adopted ICH E6(R3) effective April 1, 2026, making it the cornerstone of GCP compliance for clinical trials conducted in Canada.
Key Regulatory Frameworks:
| Market | Framework | Application |
|---|---|---|
| Health Canada | Part C, Division 5 of the Food and Drug Regulations | Clinical trials involving human subjects |
| Health Canada | ICH E6(R3) GCP (adopted April 1, 2026) | Ethical and scientific quality standards |
| Health Canada | Food and Drugs Act | Legislative authority |
| ICH | ICH E6(R3), E8(R1), E2 Series, E3, E9, E11(R1), E19 | International harmonisation standards |
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.
This comprehensive training program provides clinical research professionals with the knowledge and practical skills required to conduct clinical trials in compliance with Health Canada Food and Drug Regulations (Part C, Division 5) and the ICH E6(R3) Good Clinical Practice (GCP) guideline.
The curriculum is aligned with Health Canada's adoption of ICH E6(R3) effective April 1, 2026.
This training program defines the complete knowledge and performance requirements for personnel involved in clinical research to become certified global auditors for Good Clinical Practice (GCP).
The program integrates GCP requirements from ICH E6(R3), Health Canada Part C, Division 5 of the Food and Drug Regulations, and FDA regulations (21 CFR Parts 50, 56, 312, 314.50, and 314.80) with auditing practices based on ISO 19011:2026 for internal, second-party (vendor/CRO/site audits), and global regulatory compliance auditing.
Enroll in GCP Global Auditor CertificationThis comprehensive training program provides an in-depth exploration of the ICH E6(R3) Good Clinical Practice guideline, the globally recognized standard for the ethical and scientific quality of clinical trial design, conduct, and reporting.
Finalized in January 2025, this latest revision represents a significant modernization of GCP principles, emphasizing a risk-based, proportionate approach to trial management and the integration of digital technologies.
Enroll in Good Clinical PracticesThis 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.
Enroll in ISO 19011:2026This training program is designed to provide organizations and individuals with a comprehensive understanding of the legal, regulatory, and operational requirements for protecting health information in clinical research and healthcare delivery settings.
Enroll in HIPAA ClinicalGCP training is a regulatory requirement for all personnel involved in the conduct of clinical trials of drugs in human participants in Canada.
Health Canada conducts GCP inspections of clinical trial sites, sponsors, and CROs to verify compliance with Part C, Division 5 of the Food and Drug Regulations and ICH E6(R3) GCP. Inspection findings can have serious consequences:
Common Health Canada GCP inspection observations include:
Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that Health Canada inspectors accept during inspections.
Canada joined the Pharmaceutical Inspection Co operation Scheme (PIC/S) — the international body that harmonises GMP and GCP standards across 55 member countries. This has direct implications for how GDP training is structured for Canadian professionals.
Health Canada GDP requirements are closely aligned with EU GDP and WHO GCP — meaning training that covers PIC/S harmonised GDP principles is relevant for Canadian professionals working in any international context.
Canadian facilities with Health Canada GCP certification are recognised by many international regulators. Our training covers the core GDP principles recognised by all PIC/S member authorities — including FDA, EMA, and WHO.
Canadian distributors supplying the US, EU, or other markets must meet multiple regulatory frameworks simultaneously. Our GDP courses cover all relevant frameworks in a single, comprehensive program.
Training your entire QA, warehouse, or transport team? We offer group enrollment for Canadian pharmaceutical logistics companies of all sizes. Group quotes provided within 24 hours.
| Feature | GxP Trainings |
|---|---|
| Health Canada Part C, Division 5 aligned | |
| ICH E6(R3) GCP aligned | |
| FDA 21 CFR Parts 50, 56, 312 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 |
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 inspectors accept during inspections.
Health Canada adopted ICH E6(R3) effective April 1, 2026.
Under C.05.012 of the Food and Drug Regulations, records must be retained for 15 years.
Completion of basic GCP awareness training of at least four hours or equivalent on the job experience, and at least six months of experience in clinical research.
Yes. We offer corporate and group enrollment options for teams of all sizes. Contact us for a custom quote.
All courses include lifetime access — study at your own pace, on your own schedule.
Yes. Each certificate includes a unique verifiable ID that can be checked at gxptrainings.com/verify-certificate/
Equip yourself and your team with the GCP knowledge and documented training records required for Health Canada, FDA, and WHO inspection readiness.