TEST METHOD VALIDATION Randall J. Troutman CPP Senior ...
TEST METHOD VALIDATION Randall J. Troutman CPP Senior ...
TEST METHOD VALIDATION Randall J. Troutman CPP Senior ...
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• FDA “hot button” issue -<br />
What is all the buzz?<br />
– Recent release of revised 11607 documents have caused<br />
confusion in regards to listed test methods<br />
– Test method validation statement in both parts<br />
• Part 1 - Clause 4.4 Test Methods<br />
• Part 2 - Clause 4.3 Test Methods<br />
– This statement was included in the previous revision<br />
• ISO 11607 Clause 4.3.2
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