To protect drug product and drug substances, statistical methods to identify critical process parameters and critical material attributes, as well as and approaches to control them, are needed. A key ...

New integration and patterning schemes used in 3D memory and logic devices have created manufacturing and yield challenges. Industrial focus has shifted from the scaling of predictable unit processes ...

In the recently issued case of ClearValue, Inc. v. Pearl River Polymers, Inc., Judge Moore, writing for the Federal Circuit panel, distinguished the holding in the 2006 case of Atofina v. Great Lakes ...

There are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular ...

Process engineers and integrators can use virtual process modeling to test alternative process schemes and architectures without relying on wafer-based testing. One important aspect of building an ...

In today’s highly regulated environment for drug development and manufacturing, new challenges have emerged from internal pressures to reduce costs by eliminating waste in the development process, ...

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 ...