Are you ready for ICH Q14: Analytical Procedure Development and the revision of ICHQ2(R1) Analytical Validation? These guidance’s, intended to be published by 2021, complement Q8 to Q12 and aim to ...

Simple risk assessment. This approach may focus only on the type and complexity of the analytical procedure and its intended use. This approach would enable the establishment of a platform risk ...

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 development of drugs has brought about a revolution in human health. Guided by pharmacology and clinical sciences, and driven by chemistry, pharmaceutical research in the past has played a crucial ...

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating ...

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 ...

DUBLIN--(BUSINESS WIRE)--The "Analytical Method Validation, Verification and Transfer Virtual Seminar (Oct 7th - Oct 9th, 2025)" has been added to ResearchAndMarkets.com's offering. Dependable ...

This 2-day training course integrates the following principles of QbD and the lifecycle management approach to analytical procedures into current practices (Development, verification and transfer) to ...