Root Cause Analysis Course
Root Cause Analysis and Investigation Report Writing
You asked for it, so we delivered!
The most popular class with Allan Dewes, "Root Cause Analysis and Investigation Report Writing" is now available as an online self-study course. In 3-1/2 hours you'll learn about the tools used to conduct a thorough deviation investigation. You'll also learn great tips and get clear guidance on how to write a deviation investigation report. This class is not just theory and offers clear examples. Private email-based coaching is also available.
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