Advanced cGMP Training - Root Cause Analysis & Deviation Investigation Reports

Updated June 29, 2020

You asked for it, and we've delivered!

Root Cause Analysis and Investigation Report Writing - an online self-study course

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.


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.

Pricing | Questions

• If you have questions, call us: (415) 948-5220 

- - -  original post follows below  - - -

Advanced cGMP Training

Advanced GMP Training - Root Cause Analysis & Deviation Investigation Report Writing

Pinpointing the wrong cause (for example, a "false" root cause) can result in ineffective immediate, corrective, and preventive actions.

• Throwing fixes at the wrong things might not fix the problem.
• Blaming and overusing human error as the root cause can result in incomplete and ineffective root cause analysis.

By taking our advanced courses, you'll more confidently identify the real root causes, and craft clearer and more concise investigation reports.

These highly popular advanced cGMP training classes are taught at the location of your choice. You might be interested in two of our highly inter-related courses.

Root Cause Analysis for Better Deviation Investigations: On-site Advanced GMP Training by SkillsPlus International Inc.  

     Course Objectives:

• Use tools and techniques to effectively identify the deviation statement
• Identify the root cause of the deviation. 
• Generate and objectively select the best corrective and preventive actions.
• Assess the risk of implementing the corrective action and preventive action.
• Develop a contingency plan to preventive action implementation.
• Create corrective actions and preventive action metrics. 

Deviation Investigation Reports: On-Site Advanced GMP Training by SkillsPlus International Inc.
      Course Objectives:

• Increase investigation report suitability for FDA review. 
• Decrease the number of reports returned by internal reviewers. 
• Write supported deviation statements. 
• Provide a detailed background statement to include related information, investigations, affected materials and references. 
• Document deviation investigation findings. 
• State the root cause with supporting facts. 
• Generate supported, plausible, and defensible corrective actions. 
• Develop effectiveness measures for the corrective actions. 
• Generate realistic preventive actions. 
• Develop effectiveness measures for the preventive actions. 
• Develop a follow up plan for corrective and preventive actions. 
• Write accurate executive summary statements. 

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!