Conducting Advanced Root Cause Analysis and CAPA Investigations

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Inadequate investigations and CAPAs have been the #1 reason for 483 observations since 1997!

The FDA's enforcement plan makes it clear: Developing a successful CAPA program has never been more important.

But creating an FDA-proof investigation and CAPA isn’t easy.

What if you could talk with an industry leader who has spent years reading investigation reports, studying human error and performance issues, facilitating training sessions around the world, helping firms under consent decrees, and establishing investigation programs?

Well, you can.

FDAnews and LearningPlus are offering an advanced version of our previous CAPA investigations class that emphasizes investigating to find the root, contributing, and proximal causes – things that are essential to know if you want to create an effective CAPA.

In this year’s Conducting Advanced Root Cause Analysis and CAPA Investigations workshop, you will:

  • Learn how to conduct an effective, efficient investigation to avoid regulatory action and get a favorable closeout letter.
  • Discuss lessons learned from recent FDA Warning Letter citations on CAPA investigations.
  • Learn key problem-solving techniques to break a problem down into its component parts: Change Analysis, Fishbone Diagrams and Fault Trees.
  • Receive a course workbook complete with charts, forms, manuals and guidance.
  • Interact with colleagues during 12 interactive activities.

Space Is Limited — Register Today

Additional benefits you'll receive when you attend the Conducting Advanced Root Cause Analysis and CAPA Investigations include:

  • Gain valuable strategies for getting information right away in the “golden hours” after the incident.
  • Discover best practices for determining the real cause of human error with tools used by aviation accident investigators.
  • Benchmark current best practices in CAPA and investigations with your peers.
  • Learn practical strategies and techniques you can teach to all your employees.
  • Obtain sample forms for conducting investigations and case reviews.
  • Demonstrate to yourself the value of a cross-functional team and also ways that experts demonstrate their expertise
  • Understand the four elements of a well-written report and how to coach employees on report writing.


Click here to view the agenda

Your valuable course materials book is packed with tools and reference data you can put to use right away, including:

  • Forms and tables used in risk assessements
  • How to respond to FDA Form 483s
    and warning letters
  • Current FDA regulations
  • Pertinent guidance documents
  • FDA inspection manuals
  • FDA's out-of-specification guidance
  • ICH E6 good clinical practice guidance
  • Recent citations from FDA Form 483s or EIRs
  • Pertinent FDA warning letters
  • Sample investigation plan
  • Sample case review form
  • 16 great interviewing tips
  • FDA field alert; MDR, BPDR, AE forms
  • FDA recall guidance
  • Fishbone cause and effect diagrams
  • Tips on documenting/presenting root causes
  • Preventive action flowchart
  • Sample interview forms
  • Investigation data collection worksheet
  • Known/unknown worksheet
  • CAPA checklist
  • Mock failure investigation reports
  • Tips on conducting out-of-specification investigations
  • Compliance tips/best practices
  • Key chapters on investigations from GMP in Practice by James L. Vesper



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