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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2014 GMP Training Recommendation - Root Cause for Deviation Investigations Workshop

Do your firm's   Planning for Training 2014!  2014 is just around the corner!  Do your firm's investigations conclude no assignable root cause, or Do your firm's investigations conclude the root cause was human error, or Do your investigations fail to identify product impact? If you answered "Yes" to one or more of these questions, then take a look at our Root Cause for Deviation Investigations workshop.

 

Featured Course Root Cause Analysis of Deviations: This course is more than idle chat. In this workshop, students apply root cause analysis tools to real in-plant deviations.   Tools addressed in this very popular workshop: 1. 5-Whys In-depth Map 2. Sequence of Events 3. Distinctions 4. Walk Through Analysis 5. Change Analysis 6. Control Barrier Analysis 7. Fishbone Diagrams and more!   If your firm is not satisfied with the quality of deviation investigations, then you need to look into our Root Cause Analysis of Deviations workshop!   Examine The Root Cause Analysis - Investigation of Deviations Outline      Allan Dewes, President.   About Your Instructor Allan Dewes Allan Dewes has worked on deviation investigations and trained others to do the same for over 30 years. Allan understands CGMP regulations, the FDA expectations, and how to make deviation training effective and fun.   Email today to request a quotation

 

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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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