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Writing Investigation Reports
Purpose To use the data collected in an investigation to write a report and answer management and FDA questions.
Objectives 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.
About the Class 1. In-house investigation reports will be used to demonstrate and practice the skills and principles of this class. 2. This class is best taught in a compute training room. If non is available we can ship enough computers to your site for everyone to use one for the duration of the class. 3. The optional final exam is approximately 25 questions. 4. Each student receives a student guide containing a representation of the program’s slides and graphics with space provided for note taking. 5. This class can accommodate up to 12 people. 6. Duration: 8 hours.
Topics
Introduction 1. Regulatory citations 2. Regulatory requirements 3. Definitions 4. Writing guidelines
Deviation Statement 1. Components 2. Questions for clarification 3. Expected performance versus actual practice or deviation 4. Gap assessment 5. Examples 6. Activity: Writing clinic
Background Information 1. Related information 2. Previous related investigations 3. Other affected materials 4. References 5. Examples 6. Activity: Writing clinic
Deviation Investigations 1. Investigation findings 2. Chronology based reports 3. Incident based reports 4. Activity: Writing clinic
Root Cause Analysis 1. Categories 2. Assumptions made 3. Questions answered 4. Root cause options 5. Root cause statement 6. Activity: Writing clinic
Corrective Actions 1. Path forward 2. Rationale 3. Expected outcome and completion date 4. Metrics 5. Activity: Writing clinic
Preventive Actions 1. Path forward 2. Rationale 3. Expected outcome, and completion date 4. Metrics 5. Activity: Writing clinic
Executive Summary 1. Stating the root cause 2. Summarize the important points of the investigation that support that root cause 3. Stating corrective action 4. Stating preventive action 5. Activity: Writing clinic
To speak with the lead instructor for this class please call Allan Dewes at 415.487.3500 or submit the information request form below.
©2008 SkillsPlus International Inc.
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