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.

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

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SkillsPlus Intl Inc. - GMP Compliance Training Experts website

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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