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