For laboratories that operate within a quality management system, compliance with global standards such as ISO 9001, ISO 13485, ISO 17025, ISO 15189, GxP, and other country-specific regulations ...
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 This article compares the pertinent aspects of the US Food and Drug Administration's 2009 draft guidance for industry on process validation (1) ...
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 ...
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 ...
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 ...
For laboratories that operate within a quality management system, compliance with global standards such as ISO 9001, ISO 13485, ISO 17025, ISO 15189, GxP, and other country-specific regulations ...
(MENAFN- GlobeNewsWire - Nasdaq) FDA Warning Letters highlight critical cGMP deficiencies in V&V planning. Discover how to optimize Master Validation Plan elements against ISO 14971 for effective ...
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