Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

In the pharmaceutical and biotechnology sector, validation is a mandated practice integral to the entire drug development process, particularly in the context of computerized systems and manufacturing ...

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T ...

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 ...

In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...

In-line UV spectroscopy allows real-time monitoring of cleaning processes, enhancing process control and compliance with Pharma 4.0 goals. The method provides continuous detection of residual cleaning ...

Safety and efficacy are the two regulatory benchmarks for pharmaceutical products. Microbial contamination of products is an important aspect of product quality that can affect both safety and ...

This webinar course covers a variety of topics on validation of pharmaceutical product and process according to FDA standards and others.

A variety of modern innovative analytical instruments, ranging from a simple apparatus to complex computerized systems, are used in the pharmaceutical sector to get accurate data and to help ensure ...