Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...
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, ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
Every product has defects. Finding them as early in the development process as possible is definitely something to strive for. Building quality into software as it's being developed is far more ...
The U.S. Nuclear Regulatory Commission (NRC) issues initial licenses for commercial nuclear power plants for 40 years of operation – a period originally based on economic and antitrust considerations, ...
When The MathWorks introduced Matlab technical-computing software more than 20 years ago, many of the first users were control-system designers. Anyone who had laboriously inverted matrices by hand to ...
In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...
DUBLIN, Aug. 28, 2019 /PRNewswire/ -- The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added ...
Overview: This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting ...
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