Tuesday, February 21, 2012

Deviation Investigation Reports - Live onsite cGMP & QSR training class

Deviation Investigation Reports is a live on-site cGMP & QSR training class taught by SkillsPlus International Inc.

This class is instructor-led, and is taught at client manufacturing plant locations.

Purpose:
This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions. Students learn how to summarize the important points of the investigation that support the root causes.

Objectives:
Upon class completion, 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. 
Class Topics:
  • Incident description 
  • Investigations and affected materials 
  • Deviation investigations 
  • Corrections (path forward) 
  • Corrective actions 
  • Preventive actions 
  • Background information
For more information, visit:

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