Conducting Advanced Root Cause Analysis and CAPA Investigations

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

What if you can’t define a definitive root cause?

What is the relationship between root, contributing and proximal causes to corrections and corrective actions?

What if you could turn to an industry leader who knows exactly what to do?

Well, you can.

Jim Vesper — Director, Valsource Learning Solutions — has more than 25 years of GMP and investigation training experience, and he will provide you with invaluable insights in root cause analysis and CAPA investigations.

Join FDAnews and Jim — Nov. 14-15, 2018 in Princeton, NJ — for an in-depth discussion on how to improve your skills in performing investigations and identifying effective CAPAs by understanding the underlying “whys” and “how-tos”.

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

  • Discuss the expectations that GMP regulatory authorities have of investigations, CAPAs and investigation reports
  • Describe how accident/incident models can be used when conducting an investigation
  • Differentiate between 6 different accident/incident models
  • Differentiate between root cause, contributing causes and proximal cause
  • Discuss why human error is not a valid root cause
  • Discuss a model that can be used to illustrate multiple layers of control and mitigation
  • Identify 4 different audiences of investigation reports and what each is expecting to see
  • Identify the different sections of an investigation report and what each section should include
  • Given an investigation report with deficiencies, identify ways to improve the report

Space Is Limited — Register Today

But that’s not all. 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 components of a well-written report and Identify better ways of finding the real reasons behind the category of “human error” — and ways to better control and mitigate those factors.

Click here to view the agenda

Worth the price of admission itself are the amazing course materials. This book is packed with tools and reference data you can put to use right away, including:

  • FMEA chart
  • How to respond to FDA Form 483s
    and warning letters
  • Comprehensive CAPA bibliography
    and recommended reading list
  • Current FDA regulations
  • Pertinent guidance documents
  • FDA inspection manuals
  • FDA's out-of-specification
  • ICH E6 good clinical practice
  • Recent FDA Form 483s or EIRs
  • Pertinent FDA warning letters
  • Sample investigation plan
  • Sample case review form
  • 13 great interviewing tips
  • Preliminary Risk Analysis Example for an Incident Investigation
  • Incident Investigation Report Template
  • Investigation Checklist
  • FDA field alert; MDR, BPDR, AE forms
  • FDA recall guidance
  • How to write an executive summary
  • Fishbone cause and effect diagrams
  • Tips on documenting/presenting root causes
  • Preventive action flowchart
  • Sample interview forms
  • Sample audit "checklists"
  • CAPA checklist
  • Mock failure investigation reports
  • Tips on conducting out-of-specification investigations
  • Compliance tips/best practices
  • 25 page excerpt from the book GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry by James Vesper


Register today and enhance your skills to more effectively identify what caused an unwanted event and ways to prevent future ones.