Root Cause Analysis Course

The Basic Course - Here's what's covered in the basic class:

Root Cause Analysis

• • GMP Compliance Requirements

  • Deviation Investigation Definitions

  • Deviation Investigation Teams

  • Interviewing and Path Forward

  • Fishbone Diagrams

  • The Five Why's Map

  • Distinctions

  • Walk-Through-Analysis Change Analysis

  • Understanding Human Errors

  • Control Barriers

  • Product Impact

  • Previous Investigations (Look Back)

  • Immediate Actions

  • Containment

  • Corrections

  • Corrective Actions

  • Preventive Actions

  • Follow-Up and Effectiveness Checks

  • Risk Assessment

Investigation Report Writing

• • Writing Tips

  • Writing the Description of the Event

  • Event Classification Reporting

  • Writing Immediate Actions and Containment

  • Reporting on Previous Investigations

  • Sequence of Events (root cause discussion)

  • Root Cause Summary

  • Writing about Product Impact

  • Reporting on Corrections and CAPA

  • Reporting the Follow-Up and Effectiveness Checks

  • Background Information, Attachments and Referential Information

  • Interim Reports

About the Coaching Option (an advanced option)

This optional purchase enables the student to practice each tool or report section. Each item is submitted to Allan for his review and evaluation. The student receives feedback. The purchase buys the student 4-hours of email-based coaching from Allan. Additional 4-hour blocks can be purchased if needed.

Certificates: Students who successfully complete all topics will receive a certificate of completion via email from Allan.

Pricing | Questions? - Call (415) 948-5220 or Email to Jennifer Payne: Send email to Jennifer Payne