Applying GMP Quality Principles To Establish A Reduced Testing Program

18 August 2011, Houston, United States

Introduction

This webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices. Reduced testing will be viewed from current industry practice, the regulations, and quality principles. The reduced testing lifecycle we studied and reviewed. This includes such topics as component specifications, material qualification, supplier auditing and qualification, collaborative laboratory testing, certificates of analysis, material validation sampling, analyzing testing, qualification, and disqualification. Examples of systems will be shown. This webinar will primarily use graphics, especially flowcharts, to demonstrate the principles and increase in understanding of the topics.