CRED Practical Document Writing and Management

Learning Outcomes

 Dossier Management - how it’s recorded, maintained and archived; ● Paper ● Electronic (compatibility, size, software)  Hyperlinking  CTD granularity  Change Management  ‘Global’ dossiers  How to deal with old, historical, non-CTD, paper dossiers  Avoiding drift Wher we are now and ho o d al with old, historical, non-CTD, paper dossiers  Dossier Management - how it’s recorded, maintained and archived; ● Paper ● Electronic (compatibility, size, software)  Hyperlinking  CTD granularity  Change Management  ‘Global’ dossiers