cGMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products

13 September 2011, Palo Alto, United States

Introduction

This cGMP training will helps you in understanding systematic plan of evaluating cGMP applicable to the IND product cycle, the regulatory mandates (FDA, ICH, CHMP and the EU medicine agency), risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.