Course Overview:
The pharmaceutical, biotechnology, and medical device industries operate under stringent regulatory expectations, where the ability to properly investigate quality failures, deviations, and production issues is essential to protecting patient safety and maintaining product reliability. Yet, one of the most frequent deficiencies cited during FDA, EMA, MHRA, and PIC/S inspections is the “failure to thoroughly investigate.”
This course is designed to equip participants with the competencies needed to perform robust root cause analysis (RCA), document investigations effectively, and apply structured problem-solving methods that withstand regulatory scrutiny. Using real industry scenarios and practical examples, the training emphasizes how disciplined, systematic approaches lead to more accurate conclusions and prevent recurrence of issues.
The program also provides an in-depth look at the strategic use of Corrective and Preventive Action (CAPA). Rather than treating CAPA as a purely procedural obligation, the course shows how a well-designed CAPA system functions as a closed-loop control mechanism—driving sustainable improvements, reducing repeat failures, and reinforcing the overall Quality Management System (QMS). Updated industry expectations, including integration with risk management, data integrity, and lifecycle principles, are also covered.
Course Outline:
Day 1 — Root Cause Analysis (RCA)
• Introduction to structured problem-solving and the 8D methodology
• Comparing 8D with Six Sigma DMAIC and PDCA lifecycle approaches
• Understanding variation and its impact on problem definition and analysis
• Step-by-step walkthrough of all 8D phases, from containment to prevention
• Overview of common RCA tools (Fishbone, 5 Whys, Fault Tree Analysis, Is/Is Not, Pareto, etc.)
• Practical workshop: Develop a complete 8D report using a real investigation scenario
Day 2 — Corrective and Preventive Action (CAPA)
• Review of current regulatory expectations for CAPA (FDA 21 CFR, EU GMP, ISO 13485, PIC/S, ICH Q10)
• Clear differentiation between Corrective Action and Preventive Action
• How CAPA links with key QMS elements: deviations, complaints, audit findings, change control, and risk management
• Applying risk assessment (FMEA, risk prioritization, severity/occurrence/detectability) to CAPA decisions
• Incorporating SMART criteria into CAPA planning and documentation
• Critical components of a compliant, effective CAPA system
• Hands-on exercise: Build a CAPA plan based on RCA findings from the Day 1 workshop
Participants
This course is designed for professionals responsible for deviations, investigations, problem-solving, or CAPA within pharmaceutical, biotech, and medical device manufacturing. It is valuable for both newcomers to structured problem-solving and experienced staff seeking to strengthen their investigation and CAPA practices. A basic understanding of GMP and QMS frameworks will help participants gain maximum benefit from the program.