The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for ...
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You’ll learn about what processes needed to be ...
TESTA Analytical announce new 21CFR Part 11 compliance software for use with its popular family of NanoBrook particle sizing and zeta potential instrumentation. Determination of particle size and zeta ...
New standards may overlook critical qualification needs. This article compares the pertinent aspects of the US Food and Drug Administration's 2009 draft guidance for industry on process validation (1) ...
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