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About

Deviations & Non-Conformances, CAPA Investigation, Root Cause Analysis & Continuous Improvement is a twelve-module programme that takes learners from the moment a deviation is identified all the way through to a closed, verified CAPA whose effectiveness has been demonstrated. The course covers deviation classification, regulatory expectations, the deviation lifecycle, identification and reporting, structured root-cause analysis (5-Why, fishbone, fault tree), impact and risk assessment, corrective vs. preventive action design, documentation, trending, continuous improvement, and audit readiness anchored in real Warning Letters and EU GMP findings.

Deviations and CAPA is recommended for QA managers, manufacturing supervisors, deviation investigators, CAPA owners, internal auditors, and regulatory affairs professionals across pharmaceutical, biotech, medical-device, and clinical research operations. On completion, learners can identify and classify deviations and non-conformances correctly, run a structured investigation to root cause using the right RCA tool for the situation, perform impact and risk assessment to defensible standards, design corrective and preventive actions that survive effectiveness review, build inspection-grade documentation, trend and analyse deviations to drive continuous improvement, and present a closed, verified CAPA to inspectors from FDA, EMA, MHRA, and PIC/S.

Course Syllabus

  1. What Is a Deviation?
  2. What Is a Non-Conformance?
  3. Deviations vs. Non-Conformances
  4. Why These Events Matter
  5. The Cost of Poor Handling
  6. Cross-Industry Relevance
  7. Stakeholders in Deviation Handling
  8. The Investigation Mindset
  9. Reporting Culture
  10. Regulatory Importance
  11. The Quality Management System Context
  12. Common Misconceptions
  13. Process Improvement Approaches
  14. Tools You Will Learn
  15. Vocabulary You Will Master
  16. Cultural Indicators of Maturity
  17. Cultural Warning Signs

  1. Why Vocabulary Matters
  2. Deviation: Formal Definition
  3. Non-Conformance: Formal Definition
  4. Planned vs. Unplanned Deviations
  5. Critical Deviations
  6. Major Deviations
  7. Minor Deviations
  8. Classification Criteria
  9. Classification Decision Process
  10. Categories of Deviations
  11. Process Deviations
  12. Equipment Deviations
  13. Material Deviations
  14. Documentation Deviations
  15. Personnel Deviations
  16. Environmental Deviations

  1. The Regulatory Landscape
  2. Why Regulators Care
  3. FDA 21 CFR 211.192
  4. FDA 21 CFR 211.100
  5. EU GMP Chapter 1 PQS
  6. EU GMP Chapter 8 - Complaints and Recalls
  7. ICH Q9 - Quality Risk Management
  8. ICH Q10 - Pharmaceutical Quality System
  9. ISO 13485 for Medical Devices
  10. ISO 9001 for General QMS
  11. PIC/S Guidance
  12. Documentation Requirements
  13. Process Improvement: Compliance Programme

  1. Why Lifecycle Thinking Matters
  2. The Six Lifecycle Stages
  3. Stage 1: Identification
  4. Deviation Lifecycle - Six Stages
  5. Stage 2: Reporting
  6. Stage 3: Containment
  7. Stage 4: Investigation
  8. Stage 5: CAPA Definition
  9. Stage 6: Closure
  10. Lifecycle Quality Gates
  11. Lifecycle Timelines
  12. Lifecycle Roles
  13. Process Improvement: Lifecycle Optimisation
  14. Lifecycle in eQMS Tools
  15. Tools and Templates
  16. Daily Behaviour for Lifecycle
  17. Lifecycle KPIs to Track
  18. Lifecycle Cultural Indicators
  19. Integration with Other Systems
  20. Building Lifecycle Maturity

  1. Why Identification Matters
  2. Sources of Identification
  3. Operator Identification
  4. Supervisor Identification
  5. QA Reviewer Identification
  6. Customer-Driven Identification
  7. Why Reporting Matters
  8. What to Report
  9. When to Report
  10. How to Report Effectively
  11. Initial Information to Capture
  12. Reporting Channels
  13. The Role of Cultural Openness
  14. Near-Miss Reporting
  15. Process Improvement: Identification Maturity
  16. Recognition and Culture
  17. Identification Metrics to Track

  1. What Is Investigation?
  2. What Is Root Cause Analysis (RCA)?
  3. Why RCA Matters
  4. Root Cause Analysis Tools
  5. Levels of Cause
  6. The Investigation Mindset
  7. Investigation Steps
  8. Defining the Problem
  9. Gathering Evidence
  10. Conducting Interviews
  11. RCA Tool: 5 Whys
  12. 5 Whys Example
  13. RCA Tool: Fishbone (Ishikawa)
  14. Fishbone Categories Explained
  15. RCA Tool: Fault Tree Analysis
  16. RCA Tool: Pareto Analysis
  17. RCA Tool: Process Mapping
  18. Combining RCA Tools
  19. Cross-Functional Teams
  20. Investigation Documentation
  21. Distinguishing Symptoms from Causes
  22. Process Improvement: RCA Capability
  23. Connecting Investigation to CAPA

  1. Why Impact Assessment Matters
  2. Dimensions of Impact
  3. Patient Safety Impact
  4. Findings Severity Classification
  5. Product Quality Impact
  6. Regulatory Impact
  7. Operational Impact
  8. Financial Impact
  9. Reputational Impact
  10. Scope of Impact Assessment
  11. Risk Assessment Framework
  12. ICH Q9 Risk Management
  13. Risk Assessment Tools
  14. FMEA in Practice
  15. Risk Acceptance and Mitigation
  16. Disposition Decisions
  17. Disposition Decision Authority
  18. Customer Notification Decisions
  19. Process Improvement: Assessment Quality
  20. Linking Impact to CAPA

  1. What Is CAPA?
  2. Corrective vs. Preventive
  3. Why CAPA Matters
  4. Corrective vs Preventive Action
  5. CAPA Triggers
  6. CAPA Process Stages
  7. Defining a Good CAPA
  8. CAPA Risk Prioritisation
  9. CAPA Owners and Accountability
  10. CAPA Implementation
  11. Effectiveness Verification
  12. Effectiveness Methods
  13. CAPA Closure
  14. Process Improvement: CAPA Effectiveness
  15. CAPA Metrics to Track
  16. CAPA Cultural Indicators
  17. CAPA in eQMS Tools
  18. Building CAPA Maturity
  19. Connecting CAPA to Risk Register
  20. Senior Leadership in CAPA

  1. Why Documentation Matters
  2. Records Generated
  3. ALCOA+ for Deviation Records
  4. ALCOA+ Data Integrity Principles
  5. Initial Event Report
  6. Investigation Report Structure
  7. Impact Assessment Records
  8. CAPA Documentation
  9. Document Control
  10. Records Retention
  11. Electronic vs. Paper Records
  12. eQMS Tools
  13. Process Improvement: Documentation Quality
  14. Records and Continuity
  15. Documentation Metrics
  16. Records Across Lifecycle
  17. Integration with Other Records
  18. Regulatory Documentation Expectations
  19. Documentation as Defensibility

  1. Why Trending Matters
  2. What to Trend
  3. Trending Frequency
  4. Trend Analysis Tools
  5. Pareto Analysis
  6. Run Charts
  7. Statistical Process Control
  8. Cross-Functional Trends
  9. Key Performance Indicators
  10. Leading vs. Lagging Indicators
  11. Management Review
  12. Annual Product Review
  13. Continuous Improvement Frameworks
  14. Continuous Improvement Loop
  15. Trending Across the Lifecycle
  16. Metrics Cultural Indicators

  1. Why Audit Readiness Matters
  2. Types of Audits
  3. Self-Inspection Programme
  4. Inspection Response Workflow
  5. Audit Planning
  6. Audit Scope for Deviations
  7. Pre-Audit Preparation
  8. Inspection Day Behaviour
  9. Documents Inspectors Request
  10. Findings Classification
  11. Responding to Findings
  12. FDA Form 483
  13. FDA Warning Letter
  14. EU GMP Inspection Outcomes
  15. Process Improvement: Audit-Ready Operations
  16. Audit and Cultural Reset

  1. Why Case Studies Matter
  2. Sources of Industry Learning
  3. Patterns in Investigation Failures
  4. Patterns Across Failures
  5. Patterns in Repeat Findings
  6. What Mature Organisations Do Differently
  7. Building a Learning Organisation
  8. Cultural Indicators of Maturity
  9. Building an Industry Learning Culture

Course Benefits

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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 up to date with any changes to EU GMP Chapter 1, ICH Q9/Q10, FDA 21 CFR 211, ISO 13485, and PIC/S deviation/CAPA guidance as our training courses are constantly monitored, reviewed and updated.

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Learn from Industry Experts

The course content has been developed by industry practitioners and subject-matter experts to ensure that learners can apply the principles directly in their daily work. Every module follows a consistent rhythm — concept, regulatory context, real-world failure, audit perspective, preventive controls, and a knowledge check.


Our Certified Customers

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