Thursday, November 7, 2013

Ideas For 2014 GMP Training - Deviation Investigation Report Writing Clinic

483 Observation Gotchas!
1. Deviation reports failed to include a discussion of product impact.
2. Investigation reports stated this was an isolated incident, yet the database revealed 13 similar incidents.
3. Investigation reports failed to provide data to support the root cause determination
Planning for Training 2014!

 2014 is just around the corner! 
  1. Do your investigation reports wander all over and never get to the point, or
  2. Do deviation reports fail to document a sound root cause conclusion, or
  3. Do deviation report writers never seem to know what Quality Assurance wants discussed in the report?

    If you answered "Yes" to one or more of these questions, then take a look at our Investigations Report Writing clinic.

Featured Course
Deviation Investigation Report Writing Clinic: This course is hands-on and personal. In this clinic, students: learn about each section of your company's investigation report; write each section of the report for a real investigation report, and then; receive personal coaching privately from Allan. This course is not the typical spelling and grammar checking training program often offered.
Common sections addressed in this very popular workshop:
1. Deviation Description
2. Previous Related Investigations
3. Product Impact Assessment
4. Root Cause Investigation Discussion
5. Root Cause Determination
6. Risk Assessment
7. Corrective and Preventive Actions and more!
If your firm is not satisfied with the quality of deviation investigation reports, then you need to look into our Deviation Investigation Report Writing Clinic!

Allan Dewes
Allan Dewes, President.
About Your Instructor
Allan Dewes

Allan Dewes has been teaching others to write deviation investigation reports for over 15 years. Allan understands CGMP regulations, the FDA expectations for deviation investigation reports, and how to coach others to write a quality document.
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