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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

Effective deviation management, root cause investigation, and Corrective and Preventive Action (CAPA) are fundamental components of GxP quality systems. Organizations must identify, investigate, correct, and prevent quality issues using structured, risk-based processes that support product quality, patient safety, data integrity, and regulatory compliance. Robust investigations and effective CAPA systems are essential for demonstrating continual improvement and inspection readiness.
This GxP Deviation Management, Root Cause Investigation and CAPA Training Course & Certification provides comprehensive knowledge of deviation management processes, deviation classification, investigation planning, root cause analysis methodologies, quality risk management, CAPA development and implementation, effectiveness verification, trend analysis, documentation requirements, regulatory expectations, inspection readiness, and continual improvement within GxP-regulated environments. Upon successful completion, learners receive a certification demonstrating their understanding of deviation investigations, CAPA systems, and GxP quality management best practices.

Who Should Enrol?

  • Quality Assurance and Quality Management Professionals
  • Manufacturing, Production, and Operations Personnel
  • Quality Control and Laboratory Professionals
  • Validation, Engineering, and Technical Services Personnel
  • Regulatory Affairs and GxP Compliance Professionals
  • Internal Auditors and Inspection Readiness Teams
  • CAPA, Investigation, and Continuous Improvement Specialists
  • Anyone involved in deviation management, investigations, or quality system compliance within GxP-regulated industries
📢 Every purchase also includes our FREE companion GxP Deviation Management, Root Cause Investigation and CAPA eBook, designed to help you apply principles in real-world clinical trial settings.

What you will learn

Understand the principles of GxP deviation management, regulatory expectations, and the importance of timely identification, documentation, investigation, and reporting of deviations.

Learn how to classify deviations, perform structured root cause investigations, apply risk-based decision-making, and use proven investigation tools to identify the true cause of quality issues.

Develop knowledge of Corrective and Preventive Actions (CAPA), effectiveness checks, trend analysis, quality risk management, and integration with change control and the Pharmaceutical Quality System.

Gain practical understanding of investigation documentation, regulatory inspection readiness, continual improvement, and lifecycle management of deviations and CAPA within GxP environments.

Course Syllabus

  1. What is a deviation?
  2. Planned vs unplanned deviations
  3. Deviation vs other quality events
  4. Immediate reporting
  5. Data integrity and contemporaneous records
  6. Roles and responsibilities
  7. Event ownership and triage
  8. Deviation classification
  9. Quality-system interfaces
  10. GxP breadth
  11. Common early mistakes

  1. Containment — the first priority
  2. Stop-work decisions
  3. Quarantine and segregation
  4. Evidence preservation
  5. Notification and escalation
  6. Product and batch impact
  7. Data impact
  8. Patient and participant impact
  9. Widening the scope
  10. Risk-based prioritisation

  1. The problem statement
  2. Timeline and process mapping
  3. Records and system data
  4. Interviews
  5. Physical and electronic evidence
  6. Sampling, testing, comparators and controls
  7. The investigation team
  8. Hypothesis testing
  9. Interim reports and extensions
  10. Evidence-quality review

  1. Selecting an RCA tool
  2. Five Whys
  3. Fishbone and fault-tree
  4. Barrier and change analysis
  5. Levels of cause
  6. Human and organisational factors
  7. Multiple and unknown causes
  8. Bias and subjectivity
  9. Writing strong causal statements

  1. Correction, corrective, preventive
  2. The hierarchy of controls
  3. Training as CAPA — with caution
  4. Owners, due dates and prioritisation
  5. Change control and linkage
  6. Effectiveness criteria
  7. Monitoring and unintended consequences
  8. CAPA closure

  1. Backlog and ageing
  2. Extension governance
  3. Repeat deviations and cross-site learning
  4. Quality metrics
  5. Reading metrics — interpretation
  6. Management review and escalation
  7. Inspection readiness
  8. Common deficiencies to avoid

  1. 📘 Bonus: GxP Deviation Management, Root Cause Investigation and CAPA eBook (Free with purchase)

Course Benefits

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Free eBook

Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever

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CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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Keep Up to Date

You will stay aligned with current effective texts including ICH Q10 and ICH Q9(R1), EudraLex Volume 4 Chapter 1 and relevant EU GMP chapters, FDA 21 CFR 211.192 and 211.194 and the FDA OOS guidance (Level 2 revision, May 2022), and MHRA GMDP inspectorate guidance on investigations and root cause analysis. Draft or consultation material is clearly flagged.

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Learn from Industry Experts

Content reflects the combined practice of quality investigators, deviation-system owners, CAPA specialists, quality-risk-management practitioners and GMP auditors, expressed through worked examples and an integrated case study.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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