Articles by Thomas A. Little, PhD - BioPharm International

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Articles by Thomas A. Little, PhD

Essentials in Quality Risk Management

Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
May 1, 2013

Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.

Assay Development and Method Validation Essentials

A 10-step systematic approach to analytical method development and validation can improve the quality of drug development.
Nov 1, 2012

A 10-step systematic approach to analytical method development and validation can improve the quality of drug development.

Using a Systematic Approach to Select Critical Process Parameters

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.
Jul 1, 2012

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.

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