Investigation Reports
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Give us a call at (415) 487-3500   Let's discuss your training needs!

 

We also recommend: [Root Cause Analysis for Better Investigations] [Human Errors - Overcoming The Challenges]  [Risk Assessment: CGMP/QSR for the 21st Century]

 

Deviation 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 deviation reports will be used to demonstrate and practice the skills and principles of this class.

  2. This course is best taught in a computer lab. We can ship computer labs to your site if needed.

  3. 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.

  4. The optional final exam is approximately 25 questions.

  5. Each student receives a student guide containing a representation of the program's  slides and graphics with space provided for note taking.

  6. This class can accommodate up to 12 people.

  7. Duration: 8 hours as a minimum. 

Topics

 

Introduction

1.   Observations from the FDA

2.   Regulatory requirements

3.   Definitions

4.   Writing guidelines

5.   Common writing traps

 

Description of Incident

1.   Components

2.   Questions for clarification

3.   Expected performance versus actual practice or deviation

4.   Immediate response

5.   Examples

6.   Activity: Writing clinic

 

Other Investigations and Affected Materials

1.   Related investigations

2.   Other effected materials

3.   Examples

4.   Activity: Writing clinic

 

Deviation Investigations

1.   Investigation findings

2.   Sequence of events

3.   Anticipating root cause questions from the FDA

4.   Discussion of root causes eliminated

5.   Discussion of most likely root causes

6.   Discussion of the real root cause

7.   Handling no assignable root cause

8.   Activity: Writing clinic

 

Path Forward (Corrections)

1.   Path forward

2.   Rationale

3.   Expected outcome and completion date

4.   Follow up on Path Forward success

5.   Activity: Writing clinic

 

Corrective Actions

1.  Corrective action

2.   Rationale

3.   Expected outcome and completion date

4.   Follow up on CA success

5.   Activity: Writing clinic

 

Preventive Actions

1.   Preventive action

2. Rationale

3.  Expected outcome, and completion date

4.   PA Implementation

5.   Follow up on CA success

6.   Activity: Writing clinic

 

Background Information

1.    Rationale

2.    Content

3.    Activity: Writing clinic

 

Summary

1.   Summarize the important points of the investigation that support that root cause

2.   Activity: Writing clinic

Call to learn about how we can customize this outline for any of your site's  training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.487.3500.

 

For a prompt reply to requests and questions:  415.487.3500   |  allan.dewes@skillsplusinc.com   |   Fax: 954.566.5225

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