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 ...

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 ...

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 ...

The purpose of this course is to provide candidates with some practical tools for validation - including qualification, process validation and analytical method validation. Validation is a regulatory ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

Dublin, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The "3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH" training has been ...

In this article, the author modestly expresses his views on the use and understanding of linearity, a key parameter to be determined in analytical method validation in quality control laboratories (QC ...

Dublin, Dec. 04, 2024 (GLOBE NEWSWIRE) -- The "Analytical Methods Validation for FDA Compliance Drugs and Biologics" training has been added to ResearchAndMarkets.com's offering. Dependable analytical ...