Practical Management of Impurities

8 - 9 March 2018, Clearwater Beach, United States

Introduction

Effective Management of Impurities within Pharmaceuticals is an integral part of the overall development process and a central core of the control strategy. This course aims to provide an in depth examination of the key principles associated with the management of all key impurity classes and within each provide an overview of the current state of the art. It will look to examine how to apply a risk based approach to impurity identification, assessment and management and how to relate this to manufacturing processes and ultimately the overall control strategy. To ensure that not only are impurities controlled in line with regulatory requirements but also that the associated control strategy allows rather than hinders effective process optimisation.