Enhancing Investigations with Human Factor Insights
What you'll gain from this course
This in-depth training course is specifically designed for professionals in the pharmaceutical and biopharmaceutical industries who are responsible for investigating deviations, non-conformances, OOS results, and other quality events.
The course is a learning journey that provides participants with a thorough understanding of how to perform effective, compliant investigations that meet regulatory expectations and drive continuous improvement in quality systems, reducing likelihood of repeat issues.
Participants will learn to apply methodologies like the 5 Hows, Ishikawa diagrams, and fault tree analysis to identify root causes—not just symptoms—while emphasizing the importance of understanding Human Factors and the connection between investigations and effective risk-based Corrective and Preventive Actions (CAPA).
Key Features
- Real-world examples and case studies from pharmaceutical operations
- Practical group exercises to reinforce learning
- Focus on both technical and behavioural contributors to quality issues
- Templates and tools to standardise investigation processes
- Insights into regulatory inspection trends and how to avoid common pitfalls
Course Tutor
Marie O’Callaghan – Marie is an experienced pharmaceutical professional with extensive experience in biologics and aseptic manufacturing. Eligible to act as a Qualified Person (QP), Marie has worked with both oral dose and sterile products. Her hands-on experience in deviation investigation and review underscores her commitment to quality and continuous improvement. Marie is passionate about optimizing investigations and leveraging human factors to enhance processes.
Learning Outcomes
- Understand the regulatory requirements (e.g., FDA, EMA, ICH) related to quality investigations related to risk-based investigations
- Learn structured methodologies for root cause analysis
- Develop effective problem statements and hypotheses
- Differentiate between human error (1st Story) and system issues (2nd story), and apply appropriate risk-based CAPA strategies
- Effective use of hierarchy of Control for CAPAs. The lower you go in the hierarchy, the more dependent you are on human behaviour and repeat mistakes are more likely
- Enhance investigation report quality and response to regulatory inspections
Who Should Attend
This course is ideal if you:
- Are responsible for investigating deviations, non-conformances, OOS results, and other quality events
- Have had issues with your deviations raised in your latest (and previous) inspections, especially problems that have not been fully investigated or are repeat issues
- Are committing a lot of time and effort on investigations but not effectively addressing the issues you are finding
Need help choosing?
Our training advisors can help you find the perfect match.