Deviation Investigation Reports - Training Class

Updated June 3, 2020

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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.)


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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.

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