The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for ...
The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them. In November 2008, the US Food and Drug Administration issued Draft Guidance for ...
In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...
Utilising extensive knowledge of ICH guidelines, this course will outline and define best practice in the approach and requirements for Process Characterisation and Qualification (Validation) studies, ...
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