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Course Schedule |
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Handling of Out of Specification Results & Lab Deviations
| $1,200(USD) |
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R1845A |
Two Days |
Workshop |
| $1,392(CAD) |
| Description: |
The scope of this workshop covers performing an investigation from the point of event observed/discovered through CA/PA closure and verification.
This workshop will provide an overview of techniques, including strategy meetings, root cause analysis, compilation and evaluation of supporting data and writing a comprehensive, compliant Investigation Report.
An interactive workshop using industry related examples resulting in investigation quality improvement and deviation reduction.
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| Outline: |
- Day One
- I. Introduction and Workshop Objectives
- II. Why are you required to perform an Investigation?
- A.Corporate Policy
- B.Regulatory Requirment
- C.Key Elements of the Investigation Process
- III. What is an event?
- IV. What do you do first?
- A.STOP
- B.Assess/Evaluate
- C.Next Step
- V. What is a Deviation?
- A.Documentation requirements of the deviation
- B.What is an “Immediate Action”
- C.What is an “Impact Assessment”
- D.Classification of the deviation
- VI. How to perform an investigation
- A.Strategy Meeting
- B.Collecting Information
- C.Assessment
- VII. Root Cause Analysis
- A.Qualitative Tools
- - Brainstorming
- - Cause and Effect
- - 5 Whys
- Day Two
- B.Quantitative Tools
- - Process Mapping
- - Trending Charts
- - Pareto Charts
- C.How to evaluate all potential root causes
- - Decision Making Process
- VIII. CA/PA
- A. Definition
- B. Pitfalls
- IX. The Investigation Report
- A. Compile Thoughts
- B. Report Draft
- X. The Investigation Package
- A. What does it look like
- B. Expectations
- C. The Final Report
- Breakout Sessions
- Exercises are included throughout the 2-day session.
- Objective: To apply course theory in performing and documenting laboratory investigations.
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| Prerequisites: |
None. |
| Equipment: |
None. |
| Student Profile: |
Personnel conducting Investigations. |
| Course Calendar: | On Demand |
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