PharmTech

Process Validation: Do We Need Brainwashing?

In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA radically changed its interpretation of process validation. Validation now means “the collection and ...
Yahoo Finance

Biopharmaceutical Manufacturing Process Validation: Understand FDA Guidance and EU Guidelines (Nov 17th - Nov 18th, 2025)

Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...
PharmTech

Lifecycle-Based Process Validation Emphasizes the Need for Continued Process Verification

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 ...
Royal Society of Chemistry

FDA's New Process Validation Guidance - Webinar By GlobalCompliancePanel

Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official ...