In highly regulated industries, quality and validation procedures can be make or break, and getting them right requires working with system integrators who have industry-specific experience. My first ...
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 ...
Dr. Mohsen Taheri-Andani and Dr. Yash Parikh are collaborating on a project aimed at revolutionizing the additive manufacturing landscape by reducing the time and cost associated with operational ...
For more than 15 years, Aldo Vidinha has worked at the intersection of engineering, quality, and regulatory strategy in the ...
The purpose of this course is to provide candidates with some practical tools for validation - including qualification, process validation and analytical method validation. Validation is a regulatory ...
Dublin, May 30, 2024 (GLOBE NEWSWIRE) -- The "Process Validation with Qualification Training Course" conference has been added to ResearchAndMarkets.com's offering. Attending this invaluable two-day ...
Metrohm’s response to Analytical Instrument Qualification is contained within the Metrohm Compliance Services document, while the most detailed level of documentation offered for AIQ is the IQ/OQ.
(click to enlarge)This is an example of a table that would be included in a qualification protocol in a prerequisites test section. An official copy of the protocol is printed and the tester fills in ...
Skill levels generally differ between plant operator shifts. Further, these differences often cause divides among the shifts that result in unequal divisions of responsibility. Comprehensive, ...
Celltrion has begun the final validation process for its third plant in Songdo, Incheon, before commencing commercial production, the South Korean biosimilar giant announced Tuesday. The validation ...
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