Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...

Identifying constraints explicitly in the design-input document facilitates project management and reduces risk. by Gerald E. Loeb and Frances J. R. Richmond Figure 2. Display window containing ...

In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...

Batch remains advantageous for development, variable demand, and bounded risk, benefiting from natural hold points, simpler investigations, and lower upfront capital, despite longer lead times and ...

Diagnostic test developers, including clinical laboratories, responded to the COVID-19 pandemic with inspiring creativity to meet patient testing needs. These developers found unique ways to enable ...

Bioprocessing is an umbrella term that describes the research, development, manufacturing, and commercialization of products derived from or used by biological systems. For industrial purposes, ...

The process control and instrumentation minor emphasizes developing skills and knowledge in theory, software and in the field. Students graduate ready to solve complex control problems in the chemical ...

In this article, as in industry, advanced process control (APC) refers primarily to multi-variable control. Multivariable control means adjusting multiple single-loop controllers in unison, to meet ...