Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...
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 ...
We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...
This paper briefly discusses the approaches for Validation Environment and Test methodologies adopted for 8-bit microcontroller family based products. We would be focusing on modularity and the need ...
I’ve spent the past six months leading market validation as we prepared to launch the most significant enhancement to our product yet. It was a robust and rewarding process, including one-on-one ...
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, ...
SK hynix completed the development of the industry-leading 10-nanometer process technology-based fifth-generation DDR5 DRAM and entered a product validation process with U.S. chip giant Intel, the ...
A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...
Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...
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