Compiling the Design History File, and Technical File / Design Dossier - Webinar by GlobalCompliancePanel

22 September 2010, United States

Introduction

This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented. Major modules of a DHF SOP and a TF / DD SOP will be presented and discussed -- the webinar will address the development of a new, or revision of an existing DHF SOP and TF / DD to ensure they meet regulatory expectations and assist those charged with compiling, updating and/or revising these mandatory documents.C15