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| Course Information |
Course Schedule |
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Performance Verification Workshop
| $1,200(USD) |
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R1712A |
Two Days |
Workshop |
| $1,200(CAD) |
| Description: |
The scope of this workshop covers the execution and documentation of Analytical Instrumentation Performance Verification, from ensuring system
readiness, writing and execution of a protocol, through final Summary Report. |
| Outline: |
- Day One
- I. Introduction and Workshop Objectives
- II. Definitions and Pre-requisites
- III. Installation Qualification (IQ)/Operation Qualification (OQ)/Performance Qualification (PQ)
- A.Regulatory Expectation
- B.Your Expectation
- C.Key Elements
- D.Documentation
- IV. Pre-Validation
- A. Benefits
- B. Recommendations
- V. Performance Verification
- A. Performance Verification versus Analytical Method Validation
- B. Regulatory Expectation
- C. Your Expectation
- D. Key Elements
- E. Documentation
- F. Requirements
- - Validated Test Methods
- - Standard Test Methods
- - Non-Validated Test Methods
- Day Two
- VI. The Verification Summary Report
- VII. The Verification Package
- A. What does it look like
- B. Expectations of an auditor
- VIII. Breakout Sessions
- IX. Open Discussion
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| Prerequisites: |
None. |
| Equipment: |
None. |
| Student Profile: |
Personnel involved in Instrumentation Maintenance, Laboratory Personnel. |
| Course Calendar: | On Demand |
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