Conducting Advanced Root Cause Analysis and CAPA Investigations

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CAPA has 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 CAPA isn’t easy.

If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA.

Well, you can.

FDAnews and Immel Resources are offering an advanced version of our previous CAPA investigations class — fully updated to meet tough FDA scrutiny in 2014.

NEW for 2014

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

  • Learn how to respond to the FDA and implement effective CAPAs to prevent regulatory action and get a closeout letter.
  • Get an insider’s view of the FDA's own training program for investigators, with portions of the Reid Technique DVD reviewed during the course.
  • Discuss lessons learned from nine years of FDA warning letter citations on CAPA investigations.
  • Learn key problem-solving techniques to break a problem down into its component parts: CIA, Kepner-Tregoe and FMEA.
  • Receive a course workbook complete with charts, forms, manuals and guidance.
  • Interact with colleagues during 8 exercises.

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 performing in-depth interviews and determining individuals responsible for an event.
  • Discover best practices for training, assigning and managing your lead investigators, using proven law enforcement techniques.
  • Benchmark current best practices in CAPA and investigations with your peers.
  • Learn 22 great investigative tools you can teach to all your employees.
  • Obtain sample forms for conducting investigations and case reviews.
  • Review required FDA notifications, such as field alerts, medical device reports, biologic product deviation reports, adverse events, serious adverse events, recalls, corrections and removals.
  • 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:

  • 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
  • Three articles on problem investigations
  • FDA inspection manuals
  • FDA's out-of-specification guidance
  • ICH E6 good clinical practice guidance
  • Recent FDA Form 483s or EIRs
  • Pertinent FDA warning letters
  • Sample investigation plan
  • Sample case review form
  • 16 great interviewing tips
  • Two valuable articles on CAPA
  • 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



register