On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...

In today's fast-moving world of vaccines, gene therapies and biotherapeutics, computerized systems play a critical role in the discovery, manufacture and delivery of potentially life-saving drugs.

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 ...

Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK guidelines, and GAMP standards grants ...

Medical device software validation is drawing increased attention from regulators, manufacturers, and the healthcare industry. Recent media articles have directed attention to the fact that the ...

General Dynamics Chairman and CEO Phebe Novakovic told investors and analysts during an earnings call last week that the company’s efforts to obtain type certification on the Gulfstream G700 in ...

This seminar will provide an overview and in-depth snapshot of the process for managing V&V activities affecting product, process, equipment and the QMS. Company employees responsible for new product ...