PharmTech

Evolution of Analytical Procedure Validation Concepts: Part I – Analytical Procedure Life Cycle and Compendial Approaches

The new industrial revolution, “Industry 4.0,” has been leading to changes in the pharmaceutical industry (“Pharma 4.0”), where significant paradigm shifts have been occurring in the pharmaceutical ...
PharmTech

Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data. The principles of quality by design (QbD) and life cycle management, as outlined in ...
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 ...
technologynetworks

Applying a Lifecycle Approach to Your Analytical Procedures and Method Validation Programs

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...