Investigation Reports
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We also recommend: [Root Cause Analysis for Better Investigations] [Human Errors - Overcoming The Challenges]  [Risk Assessment: CGMP/QSR for the 21st Century]

 

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.

Fees: 

  • Basic Course access is $995 per student. 
  • Advanced Coaching Option is $800 per student per 4-hour block of coaching time. Time is based on Allan's actual document review time and preparing feedback. Additional review time segments can be purchased. 
  • Special group or classroom rates are available.

Enroll now!  -  Purchase-Register-Enroll in the Root Cause Analysis and Investigation Report Writing course  

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

Have more questions?  -  Call Allan at (415) 948-5220 or (954) 873-7422 or Email to Allan Dewes

Bonus! - A free GMP tip on Root Cause Analysis (by SkillsPlus International Inc.)

 

For a prompt reply to requests and questions:  (415) 948-5220 |  skillsplus@aol.com    |   Fax: (954) 566-5225

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