In today’s highly regulated pharmaceutical environment, ineffective investigations and weak CAPA systems remain one of the leading causes of FDA observations and compliance failures.
This practical, results-driven training is designed to help professionals identify true root causes, avoid recurring deviations, and implement robust, inspection-ready CAPA strategies.
You will gain a clear understanding of how to move beyond superficial fixes and develop data-driven, scientifically sound solutions that stand up to regulatory scrutiny.
This practical, results-driven training is designed to help professionals identify true root causes, avoid recurring deviations, and implement robust, inspection-ready CAPA strategies.
You will gain a clear understanding of how to move beyond superficial fixes and develop data-driven, scientifically sound solutions that stand up to regulatory scrutiny.
Learning Objective
- How to conduct effective, unbiased investigations
- Proven tools and techniques for Root Cause Analysis (RCA)
- How to distinguish symptoms vs true root causes
- Designing strong corrective and preventive actions (CAPA)
- Applying risk-based approaches (ICH Q9 principles)
- Using data, trends, and statistical thinking in investigations
- Preparing inspection-ready documentation and reports
Agenda
Day 1: Investigation & CAPA Fundamentals- What is an Investigation?
- Correction vs Corrective Action vs Preventive Action (CAPA)
- Why CAPA fails in organizations
- Regulatory expectations (FDA, ICH, global trends)
- Understanding “Adulteration” & compliance risk
- Cost of poor investigations & CAPA failures
- CAPA lifecycle & workflow
- Common CAPA challenges
- What makes a CAPA system effective
- Event characterization exercise
- Identifying bias in investigations
- Learn how to identify the TRUE root cause - not just symptoms
- Data gathering & data integrity considerations
- Data mining & trend analysis
- GMP transactional mapping
- Structured RCA approaches
- Signal detection & analysis
- Null hypothesis concept (thinking scientifically)
- Introduction to DOE (Design of Experiments)
- ICH Q9 risk management principles
- Risk assessment tools (FMEA, etc.)
- Impact assessment for decision-making
- GMP awareness activity
- Turn root causes into strong, audit-ready CAPAs
- Linking root cause to CAPA
- Designing effective corrective & preventive actions
- Avoiding weak or superficial CAPAs
- Applying DOE for robust solutions
- Change management considerations
- Cross-functional CAPA execution
- Defining success metrics (CAPA efficacy)
- Verification vs validation
- Preventing recurrence
- Apply learning to real pharmaceutical scenarios
- Scenario
- Product mix-up complaint (tablet issue)
- Media fill failure investigation
- End-to-end deviation → RCA → CAPA exercise
- Group discussion & solution approach
- Presenting investigations to FDA inspectors
- Documentation best practices
- Defending CAPA during audits
- Key takeaways
- Live Q&A with expert
Course Provider
Kelly Thomas,
