Dora Endreffy

The workshop has been designed to provide practical training and guidance to those responsible for the management and operation of a GCP-regulated archive or those who need to improve their knowledge and understanding about this topic. The programme defines what constitutes an archive and the specific regulatory requirements, which apply to such facilities, highlighting any differences where they exist between different regulations. Delegates will understand how the basic principles described apply to physical records and to digital records.

Discussions will cover the following principles:

-         Records Management Principles

-         Regulatory Framework for GxP Archives

-         The GxP Archivist

-         The GxP Archive

-         Use of Third Parties