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  • Preclinical & Laboratory Foundations Learning Path
  • Phase I – First-in-Human Trials Learning Path
  • Phase II & III – Efficacy & Pivotal Trials Learning Path
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval

About

The Corrective Action and Preventive Action (CAPA) Training Course is designed to provide a clear understanding of identifying, investigating, and resolving quality issues in clinical trials and regulated environments. It focuses on strengthening quality systems through effective root cause analysis and implementation of corrective and preventive actions.
This course covers key CAPA concepts including deviation management, root cause analysis, CAPA planning, implementation, effectiveness checks, and documentation practices. It also emphasizes Good Clinical Practice (GCP) compliance, audit and inspection readiness, and risk-based quality improvement to prevent recurrence of issues. Upon completion, learners receive a certification demonstrating competency in CAPA processes.
This course covers key CAPA concepts including deviation management, root cause analysis, CAPA planning, implementation, effectiveness checks, and documentation practices. It also emphasizes Good Clinical Practice (GCP) compliance, audit and inspection readiness, and risk-based quality improvement to prevent recurrence of issues. Upon completion, learners receive a certification demonstrating competency in CAPA processes.

Who Should Enrol?

  • Quality Assurance and Quality Control Professionals
  • Clinical Research Associates (CRAs)
  • Clinical Trial Coordinators and Managers
  • Clinical Operations and Study Teams
  • Regulatory Affairs Professionals
  • Pharmaceutical, Biotechnology, and CRO Employees
  • Clinical Data and Compliance Professionals
  • Life Science, Pharmacy, Nursing, and Medical Graduates
📢 Every purchase also includes our FREE companion Corrective Action and Preventive Action (CAPA) Training eBook, designed to help you apply principles in real-world clinical trial settings.

What you will learn

Understand the fundamentals of CAPA, including definitions, core concepts, and the relationship between corrective and preventive actions.

Gain knowledge of regulatory requirements, including FDA 21 CFR Part 820.100, and why CAPA systems are essential in regulated industries.

Learn the end-to-end 7-step CAPA process, from identifying nonconformities and root cause analysis to implementation, verification, and closure.

Develop practical skills in documenting CAPA activities, ensuring effectiveness, and supporting continuous quality improvement and compliance.

Course Syllabus

  1. Definition and Core Concepts
  2. Differences and Relationship

  1. Why organisations implement CAPA systems

  1. Regulatory framework — FDA 21 CFR Part 820.100

  1. The 7-Step CAPA Process
  2. Step 1: Identification of Nonconformity
  3. Step 2: Evaluation of Nonconformity
  4. Step 3: Investigation & Root Cause Analysis
  5. Step 4: Action Plans
  6. Step 5: Implementation of Action Plan
  7. Step 6: Verification of Effectiveness
  8. Step 7: Closure

  1. What a CAPA system must achieve

  1. What to document and how
  2. Conclusion

  1. 📘 Bonus: Corrective Action and Preventive Action (CAPA) Training eBook (Free with purchase)

Our Certified Customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

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I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...

Frequently Asked Questions

The Clinical Trial Project Management Course by Whitehall Training provides a comprehensive foundation for professionals and combines standard project management methods with the specialized context of clinical research.

  • The fundamentals of clinical research and trial phases and core responsibilities and day-to-day tasks of a CRA
  • Key ICH GCP E6(R3) principles and regulatory expectations
  • How to prepare for and conduct monitoring visits
  • Risk-based and remote monitoring approaches
  • Investigational Product (IP) oversight and accountability
  • Safety reporting requirements (AE/SAE/SUSAR)
  • Site communication, documentation, and issue escalation
  • Close-out procedures and essential record archiving

This course is ideal for individuals who want to begin or advance a career in clinical research, including:

  • Aspiring Clinical Research Associates (CRAs)
  • Clinical trial site staff transitioning into monitoring roles
  • Clinical Research Coordinators (CRCs) seeking career progression
  • Professionals working in pharmaceutical, biotech, or CRO environments
  • Anyone seeking a strong foundation in monitoring, GCP, and site oversight .
No prior CRA experience is required, but familiarity with clinical research or GCP is helpful.

  • Industry-aligned CPM training with global recognition
  • Fully updated to ICH GCP E6 (R3) requirements
  • Ideal for aspiring CPMs and those transitioning from site roles
  • Practical, scenario-based learning to build real-world confidence
  • Certificate issued upon successful completion