Comprehensive online GCP training aligned with FDA regulations (21 CFR Parts 50, 56, 312, 314), ICH E6(R3), and HIPAA Privacy and Security Rules — trusted by US clinical research professionals, sponsors, investigators, and CROs. Self paced. 21 CFR Part 11 compliant certificates. Inspection ready training records.
The United States has a comprehensive regulatory framework for Good Clinical Practice (GCP) that is governed by multiple FDA regulations and the Health Insurance Portability and Accountability Act (HIPAA). These regulations specify minimum standards for the protection of human subjects, institutional review board operations, investigational new drug applications, and clinical data privacy and security.
Key Regulatory Frameworks:
| Market | Framework | Application |
|---|---|---|
| FDA | 21 CFR Part 50 | Protection of Human Subjects |
| FDA | 21 CFR Part 56 | Institutional Review Boards |
| FDA | 21 CFR Part 312 | Investigational New Drug Application |
| FDA | 21 CFR Part 314.50 | New Drug Application Content and Format |
| FDA | 21 CFR Part 314.80 | Postmarketing Adverse Drug Experience Reporting |
| FDA | 21 CFR Part 11 | Electronic Records; Electronic Signatures |
| HHS | HIPAA Privacy, Security, and Breach Notification Rules | Protection of PHI and ePHI |
| ICH | ICH E6(R3) GCP | International ethical and scientific quality standard |
All courses are self paced, available online, and include 21 CFR Part 11 compliant certificates with verifiable IDs — accepted as documented training records during FDA and other regulatory inspections.
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), FDA regulations (21 CFR Parts 50, 56, 312, 314.50, and 314.80), and Health Canada Part C, Division 5 with auditing practices based on ISO 19011:2026 for internal, second-party (vendor/CRO/site audits), and global regulatory compliance auditing.
This 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 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.
Enroll in Good Clinical PracticesThis 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.
The program covers the full spectrum of privacy, security, and compliance obligations under U.S. federal law and international good practice standards.
Enroll in HIPAA ClinicalGCP training is essential for all personnel involved in the conduct of clinical research in the USA.
The FDA conducts inspections of clinical trial sites, sponsors, and CROs to ensure compliance with GCP regulations. The FDA has implemented a program of regular inspections and data audits to monitor compliance. Inspection findings can have serious consequences:
Common FDA GCP inspection observations include:
Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that FDA 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 |
|---|---|
| FDA 21 CFR Parts 50, 56, 312, 314 aligned | |
| HIPAA Privacy, Security, and Breach Notification Rules covered | |
| ICH E6(R3) GCP aligned | |
| 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. The FDA 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 FDA inspectors accept during inspections.
Yes. Our HIPAA Clinical Data Privacy, Security & Compliance course covers the HIPAA Privacy, Security, and Breach Notification Rules, including protection of PHI and ePHI, security controls, and incident management.
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.