Empowering Membrane Process Engineers: TRUSTECH Launches the Online Assistant “MEMTOOLS” In capacity planning a ...

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 ...

This course provides candidates with practical tools for validation including, qualification, process validation and analytical method validation. Incorporating facility/equipment qualification, ...

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 ...

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 ...