Agenda eCTD & DMS Workshop
12:30 -
13:00
Registration
13:00 -
13:15
Opening and introduction (All)
13:15 -
14:15
Information Management processes
integration
for Life Sciences – from a
consultant’s perspective
(Dr. Erick Gaussens, ProductLife)
·
Document
and Content
Management
·
Regulatory submissions and tracking
·
Quality Systems
·
Insourcing and outsourcing
/ offshoring
scenarios
14.15 -
14.30
EXTEDO - Your partner for all electronic Regulatory Affairs
issues (Günter Rodenkirchen, EXTEDO)
·
Short company presentation &
overview about the product and service portfolio
14.30 -
15.30
Compliance without Complexity -
21CFR11 Compliant Document
and
Quality Management for Life Sciences
(Rainer Schwarz / Orang Gholikhani, NextDocs)
·
Company and Strategy Overview
·
Document Management System:
Regulatory Submission, SOP, Clinical Trial
·
Interoperability & Integration
·
Quality Management System : CAPA,
Deviation, Audit
15:30 - 16:00
Coffee Break
16:00
-
17:00
Why eCTD and Document Management System (DMS) belong
together (Prof. Dr. Thomas Städter, EXTEDO)
·
Document lifecycle
·
Working with templates
·
Versioning of documents
·
Collaborative work on dossiers
·
Higher quality and more secure
·
To be compliant
How to work with eCTD -
eCTDmanager presentation
·
Setup eCTD dossier - overview
·
eCTD and paper publishing
17:00 -
17:30
Q&A