CAPA, Failure Investigation and Root Cause Analysis - FDA Expectations 2015

  • 20 May 2015
  • Webinar

Description

Topics
  • What is Closed-loop CAPA?
  • U.S. FDA`s CAPA Expectations
  • Failure Investigation Using an FI Template
  • Correction, Corrective Action, Preventive Action
  • Investigation Detail - Root or Probable Cause
  • 7 Powerful Tools for Root Cause Analysis
  • Effectiveness - Determining and Monitoring
  • Impact - Often Neglected but of Major Importance
  • Institutionalize vs. Entropy
Who should Attend

Attendees from:

  • Regulatory affairs
  • Senior management
  • Production
  • Quality assurance
  • All personnel tasked with problem solving
  • R&D and engineering

Past Events

Important

Please, check "CAPA, Failure Investigation and Root Cause Analysis - FDA Expectations" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Pharma
Science: Life Sciences & Biology

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