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 ...

Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

Continued process verification for a cleaning validation program begins once the validation study is complete. Continued process verification (CPV) for a cleaning validation (CV) program begins once ...

This interactive workshop provides up-to-date, relevant and detailed information on the impact of Quality by Design (QbD) on the Development and Validation of tablet manufacturing processes. It will ...

The goal of this workshop is to provide detailed information on the implications of Quality by Design (QbD) for the validation and qualification of tablet manufacturing processes and process ...