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 ...

Process engineering expert Krishna Valluru transforms operational chaos into data-driven efficiency by fixing broken workflows and establishing data integrity.

Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official ...

Product development risks can be reduced by validating project requirements before the design process begins. Trace Baker Measured in money, time, safety, and reputation, the errors that are most ...

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ ...

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. A year’s worth of FDA warning letters suggest ...

The rate of technological advancement is increasing faster than ever before. Although the demands for meeting aggressive time-to-market requirements and innovating at warp speed are not new, they are ...