Root Cause Analysis and CAPA Implementation for GMP Compliance

Overview:

This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.

Attendees will gain insights into regulatory expectations, key RCA methodologies such as the 5 Whys, Fishbone Diagram, and FMEA, and best practices for developing and implementing effective CAPA plans to prevent recurrence. The session will also cover common pitfalls in RCA and CAPA execution, real-world case studies, and strategies to ensure compliance with FDA, EMA, and ICH Q10 guidelines.

Participants will leave with actionable knowledge to enhance their investigation processes and strengthen their GMP compliance programs.

Why you should Attend:

Participants should attend this webinar to gain essential skills in conducting effective Root Cause Analysis (RCA) and implementing robust CAPA programs-key elements for ensuring GMP compliance and avoiding regulatory issues.

Designed for professionals in quality assurance, manufacturing, compliance, and regulatory affairs, this session provides practical tools, real-world case studies, and proven methodologies to help identify true root causes, prevent recurring issues, and enhance product quality and operational efficiency. With increasing regulatory scrutiny from FDA, EMA, and other global agencies, mastering RCA and CAPA is crucial for maintaining a proactive, risk-based approach to compliance. Take advantage of this opportunity to strengthen quality systems and improve overall regulatory readiness.

Areas Covered in the Session:

• Introduction
  
  • Welcome & Objectives
    
    • Overview of webinar goals
    • Importance of Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) in GMP environments
  • Regulatory Expectations for RCA & CAPA
    
    • FDA, EMA, and ICH Q10 perspectives
    • Common regulatory citations for ineffective CAPA
• Fundamentals of Root Cause Analysis (RCA)
  
  • Definition & Purpose of RCA
    
    • Why RCA is crucial for GMP compliance
  • Types of Root Causes in GMP Settings
    
    • Human errors
    • Process deficiencies
    • Equipment failures
    • Material deviations
  • Common RCA Methodologies
    
    • 5 Whys
    • Fishbone Diagram (Ishikawa)
    • Failure Mode and Effects Analysis (FMEA)
    • Fault Tree Analysis (FTA)
• CAPA Implementation Process
  
  • Corrective vs. Preventive Actions: Key Differences
  • Key Steps in CAPA Implementation
    
    • Identify and document the issue
    • Investigate root cause (link to RCA)
    • Develop corrective actions
    • Implement preventive measures
    • Verify effectiveness
    • Document and maintain compliance records
  • Best Practices for CAPA Effectiveness
    
    • Risk-based approach
    • Cross-functional involvement
    • Continuous monitoring and review
• Case Studies & Common Pitfalls
  
  • Real-World Case Studies
    
    • Example 1: Human error in batch documentation – RCA & CAPA approach
    • Example 2: Equipment failure impacting product quality - RCA & CAPA resolution
  • Common Pitfalls in RCA & CAPA Implementation
    
    • Superficial investigations
    • Recurring deviations due to ineffective CAPAs
    • Poor documentation and follow-up

Who Will Benefit:

• Quality Assurance (QA) Professionals
• Quality Control (QC) Personnel
• Manufacturing & Production Managers
• Compliance Officers
• Regulatory Affairs Professionals
• GMP Auditors
• Operations Managers
• Process Improvement Specialists
• Validation and Engineering Personnel
• Training and Development Managers
• Risk Management Professionals
• Supply Chain and Supplier Quality Professionals