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

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, ...

I recently surveyed the on-site development of the control system for a large concentrated solar power station. This “first of a kind” facility offered many control challenges, such as balancing heat ...

A Protection and Control (P&C) design package for a typical substation includes a number of interrelated drawings, including one-line diagrams, schematic diagrams, wiring diagrams and interconnection ...

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 the development process of any new medical device, time to market is a key variable. Navigating through the design control process, it is likely that some aspects of a new product can leverage ...

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 ...

As part of a financial statement audit, auditors are required to obtain an understanding of a company's internal control system. Internal control is an interconnected web of policies, procedures, ...