Stop Blaming The Same Old "False" Root Causes

Updated May 19, 2022

Now offered as an online training program!

View advanced cGMP training courses taught by SkillsPlus International Inc.

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

.

These highly popular cGMP & QSR training classes are taught at the location of your choice, as a client on-site in-house training. You might be interested in two of our highly inter-related courses.

1. Root Cause Analysis for Better Investigations, and
2. Deviation Investigation Reports

- - - FIRST - - -

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

"Purpose:

• To conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries. 

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

About the Class
1. This class uses current deviations to practice the techniques taught.
2. The optional final exam is approximately 25 questions.
3. Each student receives a student guide containing a representation of the program's
slides and graphics with space provided for note taking.
4. This class can accommodate up to 25 people.
5. Duration: 8 hours."

'via Blog this'

- - - SECOND - - -

Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.:

Purpose:

• To use the data collected in an investigation to write a report and answer management and FDA questions.

 Objectives 

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

 About the Class

1. In-house deviation reports will be used to demonstrate and practice the skills and principles of this class.
2. This course is best taught in a computer lab. We can ship computer labs to your site if needed.
3. This course is customized to reflect your company procedure on writing deviation investigation reports. As we review that document we will make any recommendations to for change that we feel would be helpful.
4. The optional final exam is approximately 25 questions.
5. Each student receives a student guide containing a representation of the program's  slides and graphics with space provided for note taking.
6. This class can accommodate up to 12 people.
7. Duration: 8 hours as a minimum.

For more information:

• Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.
• Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Deviation Investigation Reports - Live onsite cGMP & QSR training class

Deviation Investigation Reports is a live on-site cGMP & QSR training class taught by SkillsPlus International Inc.

This class is instructor-led, and is taught at client manufacturing plant locations.

Purpose:
This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions. Students learn how to summarize the important points of the investigation that support the root causes.

Objectives:
Upon class completion, students will be able to:

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

Class Topics:

• Incident description 
• Investigations and affected materials 
• Deviation investigations 
• Corrections (path forward) 
• Corrective actions 
• Preventive actions 
• Background information

For more information, visit:

Deviation Investigation Reports is a live on-site cGMP & QSR training class taught by SkillsPlus International Inc. 

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Additional Keywords: cGMP, GMP, QSR, live,onsite,on-site,in-plant,plant,instructor-led,training,class, course, FDA, deviation, investigation,reports, CAPA, SkillsPlus

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Root Cause Analysis for Better Investigations - Live onsite cGMP & QSR training class

Root Cause Analysis for Better Investigations - onsite cGMP & QSR training by SkillsPlus International Inc.

Learn how to conduct better investigations and address CAPA regulatory requirements.  This is an instructor-led live training class, taught on-site at client locations.

Purpose of this live class: 

• Teaches students how to conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries. 

Objectives for this onsite training: 
     Upon course completion, students will be able to . . .

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

Course topics include: 

• Deviation statement 
• Deviation investigation 
• Root cause analysis 
• Corrective actions 
• Preventive actions 
• Risk analysis 
• Metrics 

For more course information: 
Root Cause Analysis for Better Investigations - onsite cGMP & QSR training by SkillsPlus International Inc.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website
Additional Keywords: biotech, cGMP, class, compliance, course, device, drug, FDA, GMP, instructor, interactive, International, manufacturer, medical, pharmaceutical, QSR, seminar, SkillsPlus, training

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Human Errors - cGMP Training

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

Learn how to overcome human errors as a root cause to deviations, when human errors are the wrong diagnosis:

Human Errors: Overcoming the Challenges - a SkillsPlus International Inc. training class

Upon class completion, students will be able to:

1. State what the cGMPs imply regarding human errors. 
2. State the FDA's current thinking about human errors and deviations. 
3. Describe the basics of root cause determination. 
4. List the possible root causes to human errors.

The course covers the following topics:

Introduction
1. Activity: Heard on the street
2. What the FDA says about human errors and deviations
3. How many human errors are too many
4. Recent 483 observations relating to human error

Understanding human error
1. The psychology of human error
2. Sources of human error

Investigating human error
1. Activity: A simple human error
2. 5-Why's
3. Sequence of events
4. Distinctions
5. Walk through analysis
6. Fish bone diagramming and root cause analysis
7. Types of root causes

Preventing human errors
1. CAPA (Corrective Action and Preventive Action)
2. Control barrier analysis
3. CGMP Challenge: Human Errors

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP Compliance Training Experts website

Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT

Deviation Investigation Reports - Training Class

Updated November 16, 2025

You might also be interested in:

Root Cause Analysis and Investigation Report Writing - Online Self-Study

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.

Learn more and buy:  Root Cause Analysis and Investigation Report Writing - Online Self-Study (by SkillsPlus International Inc.)


- - -  original post follows below  - - -

GMP Training - Deviation Investigation Reports - cGMP Training

Many FDA observations are caused by failures in deviation management and CAPA.

We can help you in this area, through this course:
Deviation Investigation Reports - a SkillsPlus Intl Inc. training class

This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions.

After completing the class, students will be able to:

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

This class is energizing and exciting, and uses the following teaching approaches:

• In-house deviation reports will be used to demonstrate and practice the skills and principles of this class. 
• This course is best taught in a computer lab. We can ship computer labs to your site if needed. 
• This course is customized to reflect your company procedure on writing deviation investigation reports. As we review that document we will make any recommendations to for change that we feel would be helpful.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP Compliance Training Experts website

Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT

Root Cause Analysis - cGMP Training Class

Learn how to conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries.

Root Cause Analysis for Better Investigations is a live training class. Upon course completion, students will be able to:

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

In-house projects will be used to demonstrate and practice the skills and principles of this class.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP Compliance Training Experts website

Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT

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Value-Packed - Overcoming the Documentation Nightmare CBT Class by SkillsPlus International Inc.

Updated March 23, 2024

The course mentioned in the post below is no longer offered.

However, you might also be interested in: 

The recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. 

#FDA #cGMP #GMP #QSR #training

Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

---  the original post follows below  ---

Our SkillsPlus International Inc. - Overcoming the Documentation Nightmare CBT Class (pdf) is intended to raise compliance awareness, and raise compliance issues for further discussion at your company.

You need this value-packed class!

• It offers high-quality online instruction from the most respected trainer in the industry
• You can take this class any time you want, at your own convenience
• For the quality and price, you can't beat the value of this class

We've designed this online course to make sure students don't get bored. The class includes video taken in a real manufacturing plant, and there are interactive quizzes with a final exam.

This computer-based class offers both depth and breadth in the main topics and sub-topics to make sure that all essential topics get covered:

1. Introduction - 483 observations related to documentation practices
2. Documentation Practices - entry, error correction, unacceptable practices, prohibited practices, falsification
3. Data Handling - rounding
4. Electronic Records - general requirements, reliability
5. Electronic Record Access - biometrics, authority checks, access controls
6. Electronic Record Security - system breach, time-out
7. Electronic Record Integrity - audit trail, record protection, record integrity
8. FDA and Documentation - request for documents, record retrieval, retention time

You need to take this value-packed class.

Go to our CBT Training webpage, and sign-up for Skillsplus International Inc. - Overcoming the Documentation Nightmare CBT Class

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Why You Need Proper Documentation Practices Training

Updated August 22, 2026

The original link broke.

You might also be interested in:

CGMP Training: A New Generation - Course Descriptions

https://skillsplusinc.com/cbpresent.htm

---  the original post follows below  ---

You’re probably asking yourself, “What’s in it for me?”

Well, are you having troubles with:

1. Proper documentation practices?
2. Error correction?
3. Unacceptable documentation practices?
4. Trying to discern electronic documentation requirements?
5. Documentation deviations?

If you answered yes to any of the above, then you need our CBT series training course:

SkillsPlus International Inc. - CBT Series - Overcoming the Documentation Nightmare