Our Most Popular FDA GMP Online Training Courses

• FDA cGMP QSR GMP Training by SkillsPlus International Inc.
• Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

Updated June 4, 2026

The most popular GMP online training classes by SkillsPlus Intl Inc.

GMP Trainer Awareness, Certification, & Master Trainer Course

Root Cause Analysis and Investigation Report Writing 

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Root Cause Analysis - Deviation Investigation Reports - Online Self-Study Course

cGMP Training - Root Cause Analysis -
Deviation Investigation Report Writing

Root Cause Analysis and Investigation Report Writing - Online Self-Study Course - FDA, cGMP, QSR, GMP Training

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.

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:  Send an email to Jennifer Payne - SkillsPlus International Inc.

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

 

Root Cause Analysis - cGMP Free Tip

• FDA cGMP QSR GMP Training - online training courses by SkillsPlus International Inc.

GMP Free Tip on Root Cause Analysis (RCA)

The FDA says, "Human error is not a root cause." If your first reflex is blaming human error, it's time to re-think the situation in order to identify the real root cause of the human error.

There are several categories of human errors: slips, lapses, and induced errors. These can account for a large percentage of errors. In order to understand these human errors in more detail, they can be investigated through the use of investigative tools such as a Walk Through Analysis or Control Barrier Analysis.

Once the underlying contributing factors and real root cause(s) are understood, then they can be controlled (in many cases).

Learn more about this topic by taking these courses by SkillsPlus Intl Inc:
Root Cause Analysis for Better Investigations - A cGMP QSR GMP Training Course
Deviation Investigation Report Writing - A GMP QSR cGMP Training Workshop


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FDA - Proposed 2016 Guidance Development & Focused Retrospective Review of Final Guidance

According to the FDA:

" . . .guidance documents that CDRH intends to publish this fiscal year (FY2016), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn. We have provided three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the “B-list”); and (3) a list of final guidance documents that issued in 2006, 1996, 1986, and 1976 subject to focused retrospective review."

Go to this FDA webpage:
CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training

Root Cause Analysis For Better Deviation Investigations - Our Most Popular cGMP Training

Updated June 12, 2025

The referenced courses are no longer available as live workshops.

You might also be interested in the online versions of these popular training courses:

Deviation Investigations and Investigation Report Writing

---  the original post follows below  ---


A GMP Training Workshop - Root Cause Analysis For Better Deviation Investigations

Still true after so many years . . . One of the top reasons for a company to receive a 483 is a deficiency in the deviation investigation process.

In our onsite hands-on workshop, employees learn the most effective tools to determine the real root cause of the problem. Attendees use actual plant deviations to practice the use of the tools.

This workshop is typically paired with another workshop for the best training results:
Writing Deviation Investigation Reports - A SkillsPlus Intl Inc. cGMP training workshop

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around

Plan Now - Choose SkillsPlus Intl Inc. cGMP Training

Updated February 27, 2026:

The new year is coming - Choose SkillsPlus International Inc. cGMP training now!

Take the next step:

• Call/email us, or visit our SkillsPlus Intl Inc. website

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around

Root Cause Analysis for Better Deviation Investigations - cGMP Training

Root Cause Analysis for Better Deviation Investigations -- A GMP Training Workshop

     -- Respected -- Popular -- Effective --

Companies often get a 483 for a deviation investigation process deficiency. Here's why training is needed:

• Teams can't solve problems, get results, or comply with FDA expectations for thorough deviation investigations. 

In this workshop, employees learn the most effective tools to find the problem's real root cause. They'll use real plant deviations to practice the tools.

To learn more:

• call Allan Dewes (415-948-5220), or
• visit  http://www.skillsplusinc.com/root_cause.htm

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Root Cause Investigations Workshop - GMP Training

ROOT CAUSE INVESTIGATIONS WORKSHOP
#FDA #GMP #QSR #cGMP #training #course #class

Learn how to dig deeper and discover what's really below the surface. In this course, students apply root cause analysis tools to real in-plant deviations.

Learn more: http://www.skillsplusinc.com/root_cause.htm

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around