CAPA and Root Cause Analysis in the Era of ICH GCP E6(R3) and AI
A free, live 2-hour webinar on how ICH GCP E6(R3) transforms CAPA from symptom-fixing to system-level, risk-based quality management — with practical AI tools for deviation analysis and root cause investigation.
Secure My Free SpotDetailed Agenda (120 Minutes)
- New R3 focus areas: proportionality and the Quality by Design (QbD) principle (Principle 6)
- Impact assessment: why CAPA is incomplete without evaluating impact on subject safety and data integrity (ALCOA++)
- Risk management lifecycle: integrating CAPA into the risk management system under ICH Q9(R1)
- RCA methodology: practical use of "5 Whys," Ishikawa (fishbone) diagrams, and FMEA in clinical quality
- The "Human Error" trap: why "staff error" alone is no longer accepted as a root cause by regulators
- AI in practice: using LLMs to classify deviations and detect trends in findings
- AI assistants to strengthen CAPA wording and consistency
- Automated search for similar historical findings in audit and inspection data
- Distinguishing CA and PA: clearly separating correction, corrective actions, and preventive actions (ICH Q10 & E6 R3)
- Effectiveness checks: defining measurable success criteria so CAPA does not become a box-ticking exercise
- Case discussions: typical critical findings from recent EMA/FDA inspection reports (2023–2025)
- Live Q&A with participants
- Practical recommendations for updating SOPs to meet E6(R3) expectations
Who Should Attend
- QA/QC Managers, Auditors, and Compliance Leads
- Clinical Operations and Trial Management Professionals
- CRAs, Monitors, and Clinical Trial Managers
- Regulatory Affairs Professionals
- Investigators, Sub-Investigators, and Site Staff
- Anyone involved in deviation handling, CAPA processes, or quality systems in GxP environments
Key Competencies You Will Gain
Regulatory Expectations
Know the specific ICH E6(R3) sections relevant to risk management and data governance, and how they reshape CAPA requirements.
Deep Analysis Skills
Distinguish between surface-level symptoms and the true root cause. Move beyond "human error" to identify systemic failures.
Technological Readiness
Understand where and how AI can safely reduce time spent on deviation handling without compromising compliance.
Your Speakers
Maxim Bunimovich
Maxim is an independent international GCP auditor and trainer with over 15 years of experience in the pharmaceutical and clinical industry across Europe, Africa, and CIS regions. A certified MRQA and SQA expert, he combines a medical background with quality management experience. He specializes in GCP audits, FDA & EMA inspection preparation (including mock inspections), and develops Quality Management Systems (QMS) for sponsors and CROs.
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Cleopatra Dimopoulos
A seasoned Quality Assurance professional with over 25 years of global experience in clinical research, bringing deep expertise in quality assurance audits, QMS management, SOP development, inspection readiness and training. Driven by the belief that quality should empower — not hinder — clinical trials, passionate about transforming audits into value-adding experiences that protect data integrity and, ultimately, patient safety.
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This is a complimentary educational webinar. Secure your spot to gain critical insights at no cost.
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