Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...
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 This article compares the pertinent aspects of the US Food and Drug Administration's 2009 draft guidance for industry on process validation (1) ...
Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Master Validation Plan - The Unwritten Requirements Course" training has been added to ResearchAndMarkets.com's offering. FDA Warning Letters and recent ...
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 ...
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 ...
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