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Deviations & Non-Conformances Course & Certification
Intermediate
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About
The Deviations & Non-Conformances Course & Certification is designed to provide a practical understanding of how deviations and non-conformances are identified, documented, investigated, and resolved in regulated pharmaceutical and life sciences environments. The course focuses on maintaining product quality, regulatory compliance, and continuous improvement through effective deviation management systems.
This course covers types of deviations and non-conformances, root cause analysis, investigation processes, impact assessment, corrective and preventive actions (CAPA), documentation requirements, and regulatory expectations. It also emphasizes quality system integration, trend analysis, and inspection readiness. Upon successful completion, learners receive a certification demonstrating competency in deviation and non-conformance management.
Who Should Enrol?
- Quality Assurance and Quality Control Professionals
- Manufacturing and Production Staff
- Validation and Engineering Teams
- Regulatory Affairs Professionals
- Clinical Research and Pharmacovigilance Teams
- Pharmaceutical and Biotechnology Employees
- Life Science, Pharmacy, Chemistry, and Engineering Graduates
What you will learn
Understand the fundamentals of deviations and non-conformances, including definitions, types, classification, and regulatory expectations.
Learn the complete deviation lifecycle, from identification and reporting to investigation, root cause analysis, and impact assessment.
Gain knowledge of CAPA management, documentation practices, trending metrics, and continuous improvement strategies.
Develop an understanding of audit readiness and real-world case studies to strengthen compliance and prevent recurrence of quality issues.
Course Syllabus
- What Is a Deviation?
- What Is a Non-Conformance?
- Deviations vs. Non-Conformances
- Why These Events Matter
- The Cost of Poor Handling
- Cross-Industry Relevance
- Stakeholders in Deviation Handling
- The Investigation Mindset
- Reporting Culture
- Regulatory Importance
- The Quality Management System Context
- Common Misconceptions
- Process Improvement Approaches
- Tools You Will Learn
- Vocabulary You Will Master
- Cultural Indicators of Maturity
- Cultural Warning Signs
- Why Vocabulary Matters
- Deviation: Formal Definition
- Non-Conformance: Formal Definition
- Planned vs. Unplanned Deviations
- Critical Deviations
- Major Deviations
- Minor Deviations
- Classification Criteria
- Classification Decision Process
- Categories of Deviations
- Process Deviations
- Equipment Deviations
- Material Deviations
- Documentation Deviations
- Personnel Deviations
- Environmental Deviations
- The Regulatory Landscape
- Why Regulators Care
- FDA 21 CFR 211.192
- FDA 21 CFR 211.100
- EU GMP Chapter 1 PQS
- EU GMP Chapter 8 - Complaints and Recalls
- ICH Q9 - Quality Risk Management
- ICH Q10 - Pharmaceutical Quality System
- ISO 13485 for Medical Devices
- ISO 9001 for General QMS
- PIC/S Guidance
- Documentation Requirements
- Process Improvement: Compliance Programme
- Why Lifecycle Thinking Matters
- The Six Lifecycle Stages
- Stage 1: Identification
- Deviation Lifecycle - Six Stages
- Stage 2: Reporting
- Stage 3: Containment
- Stage 4: Investigation
- Stage 5: CAPA Definition
- Stage 6: Closure
- Lifecycle Quality Gates
- Lifecycle Timelines
- Lifecycle Roles
- Process Improvement: Lifecycle Optimisation
- Lifecycle in eQMS Tools
- Tools and Templates
- Daily Behaviour for Lifecycle
- Lifecycle KPIs to Track
- Lifecycle Cultural Indicators
- Integration with Other Systems
- Building Lifecycle Maturity
- Why Identification Matters
- Sources of Identification
- Operator Identification
- Supervisor Identification
- QA Reviewer Identification
- Customer-Driven Identification
- Why Reporting Matters
- What to Report
- When to Report
- How to Report Effectively
- Initial Information to Capture
- Reporting Channels
- The Role of Cultural Openness
- Near-Miss Reporting
- Process Improvement: Identification Maturity
- Recognition and Culture
- Identification Metrics to Track
- What Is Investigation?
- What Is Root Cause Analysis (RCA)?
- Why RCA Matters
- Root Cause Analysis Tools
- Levels of Cause
- The Investigation Mindset
- Investigation Steps
- Defining the Problem
- Gathering Evidence
- Conducting Interviews
- RCA Tool: 5 Whys
- 5 Whys Example
- RCA Tool: Fishbone (Ishikawa)
- Fishbone Categories Explained
- RCA Tool: Fault Tree Analysis
- RCA Tool: Pareto Analysis
- RCA Tool: Process Mapping
- Combining RCA Tools
- Cross-Functional Teams
- Investigation Documentation
- Distinguishing Symptoms from Causes
- Process Improvement: RCA Capability
- Connecting Investigation to CAPA
- Why Impact Assessment Matters
- Dimensions of Impact
- Patient Safety Impact
- Findings Severity Classification
- Product Quality Impact
- Regulatory Impact
- Operational Impact
- Financial Impact
- Reputational Impact
- Scope of Impact Assessment
- Risk Assessment Framework
- ICH Q9 Risk Management
- Risk Assessment Tools
- FMEA in Practice
- Risk Acceptance and Mitigation
- Disposition Decisions
- Disposition Decision Authority
- Customer Notification Decisions
- Process Improvement: Assessment Quality
- Linking Impact to CAPA
- What Is CAPA?
- Corrective vs. Preventive
- Why CAPA Matters
- Corrective vs Preventive Action
- CAPA Triggers
- CAPA Process Stages
- Defining a Good CAPA
- CAPA Risk Prioritisation
- CAPA Owners and Accountability
- CAPA Implementation
- Effectiveness Verification
- Effectiveness Methods
- CAPA Closure
- Process Improvement: CAPA Effectiveness
- CAPA Metrics to Track
- CAPA Cultural Indicators
- CAPA in eQMS Tools
- Building CAPA Maturity
- Connecting CAPA to Risk Register
- Senior Leadership in CAPA
- Why Documentation Matters
- Records Generated
- ALCOA+ for Deviation Records
- ALCOA+ Data Integrity Principles
- Initial Event Report
- Investigation Report Structure
- Impact Assessment Records
- CAPA Documentation
- Document Control
- Records Retention
- Electronic vs. Paper Records
- eQMS Tools
- Process Improvement: Documentation Quality
- Records and Continuity
- Documentation Metrics
- Records Across Lifecycle
- Integration with Other Records
- Regulatory Documentation Expectations
- Documentation as Defensibility
- Why Trending Matters
- What to Trend
- Trending Frequency
- Trend Analysis Tools
- Pareto Analysis
- Run Charts
- Statistical Process Control
- Cross-Functional Trends
- Key Performance Indicators
- Leading vs. Lagging Indicators
- Management Review
- Annual Product Review
- Continuous Improvement Frameworks
- Continuous Improvement Loop
- Trending Across the Lifecycle
- Metrics Cultural Indicators
- Why Audit Readiness Matters
- Types of Audits
- Self-Inspection Programme
- Inspection Response Workflow
- Audit Planning
- Audit Scope for Deviations
- Pre-Audit Preparation
- Inspection Day Behaviour
- Documents Inspectors Request
- Findings Classification
- Responding to Findings
- FDA Form 483
- FDA Warning Letter
- EU GMP Inspection Outcomes
- Process Improvement: Audit-Ready Operations
- Audit and Cultural Reset
- Why Case Studies Matter
- Sources of Industry Learning
- Patterns in Investigation Failures
- Patterns Across Failures
- Patterns in Repeat Findings
- What Mature Organisations Do Differently
- Building a Learning Organisation
- Cultural Indicators of Maturity
- Building an Industry Learning Culture
Course Benefits
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.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
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.
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.
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