Course Overview
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.
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
👉 Build a strong foundation and understand regulatory expectations
Key Topics:
- 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 System Essentials:
- CAPA lifecycle & workflow
- Common CAPA challenges
- What makes a CAPA system effective
Interactive:
- Event characterization exercise
- Identifying bias in investigations
Day 2: Investigation Excellence & Root Cause Analysis (RCA)
👉 Learn how to identify the TRUE root cause — not just symptoms
Investigation Techniques:
- Data gathering & data integrity considerations
- Data mining & trend analysis
- GMP transactional mapping
Root Cause Analysis (RCA):
- Structured RCA approaches
- Signal detection & analysis
- Null hypothesis concept (thinking scientifically)
- Introduction to DOE (Design of Experiments)
Risk & Impact:
- ICH Q9 risk management principles
- Risk assessment tools (FMEA, etc.)
- Impact assessment for decision-making
Interactive:
- GMP awareness activity
Day 3: CAPA Development & Effectiveness
👉 Turn root causes into strong, audit-ready CAPAs
CAPA Planning:
- Linking root cause to CAPA
- Designing effective corrective & preventive actions
- Avoiding weak or superficial CAPAs
Execution & Implementation:
- Applying DOE for robust solutions
- Change management considerations
- Cross-functional CAPA execution
Effectiveness Checks:
- Defining success metrics (CAPA efficacy)
- Verification vs validation
- Preventing recurrence
Day 4: Real-World Case Studies & Inspection Readiness
👉 Apply learning to real pharmaceutical scenarios
Case Studies:
- scenario
- Product mix-up complaint (tablet issue)
- Media fill failure investigation
Hands-On Learning:
- End-to-end deviation → RCA → CAPA exercise
- Group discussion & solution approach
Inspection Readiness:
- Presenting investigations to FDA inspectors
- Documentation best practices
- Defending CAPA during audits
Wrap-Up:
- Key takeaways
- Live Q&A with expert
Who Will Benefit
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants; others tasked with product, process, CAPA resolution, failure investigation responsibilities
Know Your Faculty
Kelly Thomas, Head Of Quality Assurance (USA)
Highly experienced Quality Assurance / Quality Control / Regulatory Compliance leader with experience in API, biologics / biotech, both aseptic and terminally sterilized manufacturing processes, medical devices, drug / device combination products, and all pharmaceutical dosages (Sterile Injectable, OSD, Controlled Substances, Aerosols).
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.
High degree of quality understanding and ability to apply knowledge of global regulatory requirements particularly with process / equipment validation, new product and technology transfer, lot/process investigations, quality systems, quality control, data trending, lab equipment and validation.
