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 ...

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry. In the two years since the publication of FDA's final process validation guidance, how has this new ...

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 ...

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 ...

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

Despite their frequent interchangeable use, understanding the distinction between validation and qualification is critical in pharmaceutical environments. Validation is a broader concept encompassing ...