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About

The Corrective Action and Preventive Action (CAPA) Course by Whitehall Training provides a strong foundation in quality management systems, focusing on identifying, investigating, and resolving nonconformities in regulated environments. Designed for life sciences professionals, the course aligns with key regulatory requirements, including FDA 21 CFR 820.100, ISO 13485, ICH Q10, and EU GMP. Core topics include CAPA fundamentals, the difference between corrective and preventive actions, and the role of CAPA in ensuring patient safety, product quality, regulatory compliance, and continuous improvement. The course also covers CAPA requirements such as data analysis, root cause investigation, action planning, implementation, and documentation. A key focus is the structured 7-step CAPA process, along with root cause analysis tools such as the 5 Whys, Fishbone (Ishikawa) diagrams, FMEA, and Fault Tree Analysis. It also emphasizes SMART action planning, effectiveness verification, and proper CAPA closure. The course builds practical, inspection-ready skills in documentation, investigation, and compliance, ensuring that learners are prepared to support audits and maintain an effective CAPA system.

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

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...

SM

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