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

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11607 part 1 – Annex B • Includes standards from the following organizations; – ASTM (Examples – peel, dye, bubble emission, etc.) – ISO (Examples – air permeance, biological evaluation, etc.) – EN (Example – sterilization wrap requirements and test methods) – USP (Examples – Biological reactivity test, in vitro) – TAPPI (Example – dirt in paper) – DIN (Example – testing of paper board – bending stiffness)
Validation 1 General Definitions confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled Verification 2 confirmation by examination and provision of objective evidence that specified requirements have been fulfilled Qualification referred to as the process of events used to establish feasibility of a concept, process, or method 1. 11607 part 1 2. 21 CFR Part 820
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: 11607 part 1 - Annex B • What doe
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 35 and 36: Non-Standardized Test Methods • A
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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