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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.
- 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
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
- Definition and Core Concepts
- Differences and Relationship
- Why organisations implement CAPA systems
- Regulatory framework — FDA 21 CFR Part 820.100
- The 7-Step CAPA Process
- Step 1: Identification of Nonconformity
- Step 2: Evaluation of Nonconformity
- Step 3: Investigation & Root Cause Analysis
- Step 4: Action Plans
- Step 5: Implementation of Action Plan
- Step 6: Verification of Effectiveness
- Step 7: Closure
- What a CAPA system must achieve
- What to document and how
- Conclusion
- 📘 Bonus: Corrective Action and Preventive Action (CAPA) Training eBook (Free with purchase)
Our Certified Customers
Learner Rating & Reviews
Frequently Asked Questions
- 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 .
- 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









