Pharmaceutical Root Cause Analysis And CAPA Training Now Available On-Demand, Equipping Quality Teams To Investigate Deviations And Defend CAPA Before FDA Inspectors
Dublin, Nov. 12, 2026 (GLOBE NEWSWIRE) -- "Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy (June 15th - June 18th, 2026)" has been added to ResearchAndMarkets.com's offering.
Research and Markets has made the recording of“Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy” available for on-demand purchase. The four-day course, led by course provider Kelly Thomas, was held live on June 15-18, 2026. It shows pharmaceutical professionals how to move beyond symptoms to true root causes, and how to build corrective and preventive action (CAPA) programmes that stand up to regulatory scrutiny.
Key Event Facts
- Course: Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy Format: Recorded training, accessed online through a secure website Original live event: June 15-18, 2026 (EST) Duration: Four days Course provider: Kelly Thomas Regulatory focus: FDA, ICH (including ICH Q9) and GMP
Day 1: Investigation and CAPA Fundamentals
The course opens with what an investigation is, and the difference between correction, corrective action and preventive action. It then covers why CAPA programmes fail and FDA, ICH and global regulatory expectations. Participants examine adulteration and compliance risk, the cost of poor investigations, and the CAPA lifecycle. The day ends with an exercise on event characterisation and identifying bias.
Day 2: Investigation Excellence and Root Cause Analysis
Day 2 focuses on finding the true root cause rather than its symptoms. Topics include data gathering and data integrity, data mining and trend analysis, and GMP transactional mapping. Participants also cover structured root cause analysis (RCA) approaches, signal detection, the null hypothesis and an introduction to design of experiments (DOE). Risk management follows ICH Q9 principles, using tools such as failure mode and effects analysis (FMEA) and impact assessment.
Day 3: CAPA Development and Effectiveness
Participants learn to link root causes to CAPA, design strong corrective and preventive actions, and avoid weak ones. The day covers applying DOE for robust solutions, change management and cross-functional execution. It closes with effectiveness checks: success metrics, verification versus validation, and preventing recurrence.
Day 4: Case Studies and Inspection Readiness
The final day works through two case studies: a product mix-up complaint involving tablets and a media fill failure investigation. A hands-on exercise then takes a deviation through RCA to CAPA from start to finish. The course concludes with how to present investigations to FDA inspectors, documentation best practices and defending CAPA during audits.
Why You Should Watch
- Conduct effective, unbiased investigations and distinguish symptoms from true root causes Apply RCA tools, data trending and statistical thinking, including DOE Use ICH Q9 risk-based approaches and tools such as FMEA Design strong CAPAs and verify their effectiveness to prevent recurrence Prepare inspection-ready documentation and defend investigations before FDA inspectors
Course Provider
- Kelly Thomas
Quality and compliance professionals responsible for deviations, investigations and CAPA can purchase the recording through Research and Markets. Access details are sent by email.
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