BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...

This course offers an essential opportunity to enhance data integrity and compliance for cloud systems. It provides a practical model for documentation and change control, crucial for meeting ...

Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...

The form includes nine observations highlighting serious concerns over current Good Manufacturing Practices (cGMP).

This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...

Abstract: This paper tackles the challenge of automating facility inspections by detecting building components, estimating their six-degree-of-freedom (6-DoF) poses (position and orientation), and ...

Outlook Therapeutics faces a pivotal FDA decision for Lytenava on December 31st, following two prior rejections. Read why ...

Learn how the FDA approves generic drugs, ensuring their safety and efficacy while making medications more affordable.

Genentech, a member of the Roche Group, said the U.S. Food and Drug Administration approved its treatment for follicular lymphoma. The therapy, Lunsumio VELO, can be used to treat adult patients with ...

Catalent’s sweeping workforce reductions within its Maryland gene therapy manufacturing operations were preceded by two FDA inspections in April that resulted in red flags from the agency, FDA filings ...

WASHINGTON, Dec 18 (Reuters) - U.S. consumer prices rose less than expected in the year to November, but households still faced affordability challenges as the costs of basic goods and services like ...