TEST METHOD VALIDATION Randall J. Troutman CPP Senior ...

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Applying the process…. • ASTM F88-05 – Quantitative test method application – Statistical comparison of test results w/ controlled variation • ASTM F1929-98 – Qualitative test method application – Determining sensitivity levels for pass / fail tests • “In house” test method validation – Modified standard test method for use by MDM – Internal test method developed by MDM
Non-Standardized Test Methods • Acceptable for use but validation is more difficult because there is no data for comparison • You must ensure that the test is measuring the intended attribute • US regulators expect more data from the validation process
Page 1 and 2: TEST METHOD VALIDATION Randall J. T
Page 3 and 4: • Background Presentation Overvie
Page 5 and 6: 4.4 Test Methods 11607 part 1 4.4.1
Page 7 and 8: 11607 part 1 - Annex B • What doe
Page 9 and 10: Validation 1 General Definitions c
Page 11 and 12: ASTM Guidance cont. ASTM E 2282 Sta
Page 13 and 14: Definitions precision the closeness
Page 15 and 16: ASTM E 1169 Standard Guide for Cond
Page 17 and 18: ASTM E 691 Standard Practice for Co
Page 19 and 20: Definitions test method a definitiv
Page 21 and 22: ASTM E 456 Standard Terminology Rel
Page 23 and 24: Document the Exercise • The engin
Page 25 and 26: 1. Scope 1.1 method covers the meas
Page 27 and 28: Conducting a Test Method Evaluation
Page 29 and 30: Applying the process…. • ASTM F
Page 31 and 32: Conducting a Test Method Evaluation
Page 33: Conducting a Test Method Evaluation
Page 37 and 38: Randall Troutman CPP Thank You Oliv
Page 39: Additional Research • Test Method

TEST METHOD VALIDATION Randall J. Troutman CPP Senior ...

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