This course provides technicians and other professionals with a comprehensive introduction to deviation management, Root Cause Analysis (RCA), and Corrective and Preventive Action (CAPA) systems used in drug, biologic, and medical product manufacturing. Participants learn regulatory expectations, the CAPA lifecycle, Quality Risk Management (ICH Q9), and Pharmaceutical Quality Systems (ICH Q10), with emphasis on how quality events are detected, reported, investigated, and resolved. The course includes hands-on exercises using real-world scenarios to practice event reporting, RCA tools, and technical writing for investigations. Participants will develop clear, evidence-based documentation, including CAPA summaries and effectiveness strategies, and will be introduced to data trending and the appropriate use of emerging tools such as AI within a compliant quality system.
- Manufacture/Production Operators
- Team Leaders and Supervisors
- Quality Control Personnel
- Quality Assurance Personnel
- Maintenance/Engineering Personnel
- Introduction to Deviations and CAPAs
- Regulatory Drivers for Deviations, RCA, and CAPAs
- Event Detection, Reporting, and Immediate Actions
- Root Cause Analysis and Accompanying Tools
- Writing Deviations and CAPA Documentation
- CAPA Implementation and Effectiveness
- AI as a Quality System Tool for Deviations and CAPAs
By the end of the course, students will be able to:
- Define and distinguish key terms used in deviation and CAPA systems—including deviation, nonconformance, correction, corrective action, and preventive action—and explain how these elements integrate within a structured quality system.
- Describe regulatory expectations (FDA and ICH) that govern deviation investigations, CAPAs, and quality risk management, and their impact on documentation and investigation depth.
- Recognize, report, and classify quality events, including early signals, using proper documentation practices (GDP/ALCOA+) and evidence handling.
- Apply Root Cause Analysis (RCA) and risk-based tools—such as 5 Whys, Fishbone diagrams, Cause Tables —to identify true root causes and prioritize actions.
- Develop clear, accurate, and compliant investigation documentation, including problem statements, event narratives, evidence summaries, RCA conclusions, CAPA actions, and CAPA summaries using technical writing best practices.
- Design and evaluate CAPAs by linking actions to root causes, defining effectiveness criteria, applying change control, and using data trending to verify sustained improvement.
- Explain the role of data, trending, and emerging tools (including AI) in supporting CAPA systems within a compliant, human-controlled quality system.
Delivered in-person in a classroom or lab setting.
A combination of online and in-person components.
Delivered online with a live instructor at a scheduled date and time.
This course provides technicians and other professionals with a comprehensive introduction to deviation management, Root Cause Analysis (RCA), and Corrective and Preventive Action (CAPA) systems used in drug, biologic, and medical product manufacturing. Participants learn regulatory expectations, the CAPA lifecycle, Quality Risk Management (ICH Q9), and Pharmaceutical Quality Systems (ICH Q10), with emphasis on how quality events are detected, reported, investigated, and resolved. The course includes hands-on exercises using real-world scenarios to practice event reporting, RCA tools, and technical writing for investigations. Participants will develop clear, evidence-based documentation, including CAPA summaries and effectiveness strategies, and will be introduced to data trending and the appropriate use of emerging tools such as AI within a compliant quality system.
- Manufacture/Production Operators
- Team Leaders and Supervisors
- Quality Control Personnel
- Quality Assurance Personnel
- Maintenance/Engineering Personnel
- Introduction to Deviations and CAPAs
- Regulatory Drivers for Deviations, RCA, and CAPAs
- Event Detection, Reporting, and Immediate Actions
- Root Cause Analysis and Accompanying Tools
- Writing Deviations and CAPA Documentation
- CAPA Implementation and Effectiveness
- AI as a Quality System Tool for Deviations and CAPAs
By the end of the course, students will be able to:
- Define and distinguish key terms used in deviation and CAPA systems—including deviation, nonconformance, correction, corrective action, and preventive action—and explain how these elements integrate within a structured quality system.
- Describe regulatory expectations (FDA and ICH) that govern deviation investigations, CAPAs, and quality risk management, and their impact on documentation and investigation depth.
- Recognize, report, and classify quality events, including early signals, using proper documentation practices (GDP/ALCOA+) and evidence handling.
- Apply Root Cause Analysis (RCA) and risk-based tools—such as 5 Whys, Fishbone diagrams, Cause Tables —to identify true root causes and prioritize actions.
- Develop clear, accurate, and compliant investigation documentation, including problem statements, event narratives, evidence summaries, RCA conclusions, CAPA actions, and CAPA summaries using technical writing best practices.
- Design and evaluate CAPAs by linking actions to root causes, defining effectiveness criteria, applying change control, and using data trending to verify sustained improvement.
- Explain the role of data, trending, and emerging tools (including AI) in supporting CAPA systems within a compliant, human-controlled quality system.
Delivered in-person in a classroom or lab setting.
A combination of online and in-person components.
Delivered online with a live instructor at a scheduled date and time.