Failure Investigation and Root Cause Analysis - Tools and Techniques

  • Instructor : John E. Lincoln
  • Level : Intermediate
  • Study time : 99 minutes
  • Course ID: TF2580
  • Included in Subscription Pack
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ABOUT THE COURSE

Are recurring failures hurting your compliance or product quality?
Still using guesswork for root cause investigations?
Is your CAPA program truly closed-loop and audit-ready?


This session equips you with FDA-trusted tools and logic to execute systematic, repeatable failure investigations that actually resolve problems and not just document them.


WHAT WILL YOU GAIN
  • Confidence to implement robust FI & RCA programs
  • Step-by-step method to eliminate compliance gaps
  • Better outcomes from CAPA, audits, and inspections


WHY TAKE THIS COURSE
  • Move from reactive fixes to proactive quality systems
  • Reduce recalls, rework, and liability risk
  • Align every FI with real regulatory expectations


KEY AREAS COVERED
  • What a "closed-loop" failure investigation looks like
  • FDA expectations for non-conformance resolution
  • RCA tools, templates, trees, matrices, and more
  • Effective CAPA outcomes from a strong RCA base
  • V&V integration into FI and complaint handling
  • How to prove effectiveness and prevent repeat issues

Quality training, expert insights, and answers that matter. Know your Expert

JOHN E. LINCOLN

John E. Lincoln brings decades of expertise helping life sciences companies prevent failures before they happen. He's worked with teams globally to build closed-loop systems that pass audits and solve real problems. His knowledge of CAPA, complaint handling, and risk analysis is grounded in years of FDA-facing consulting. John's clarity, real-world logic, and structured FI tools make him the go-to expert for companies that want compliance without the chaos. He's also a respected author and speaker across FDA-regulated industries.

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