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Infotehna Conference with Workshop: Advanced Process and Document Management in e-Submission, QA/QC and R&D - May 19-20, 2010 (Munich, Germany)
Where: Sheraton Munich Airport Hotel, Munich, Germany
When: May 19 - 20, 2010
Infotehna’s consultants with guest speakers from Agencies and successful pharmaceutical companies will focus on areas of Quality Assurance, Quality Control and eCTD.
May 19, 2010 - Quality Assurance / Quality Control
- Change control - dangers and pitfalls/regulatory requirements, EDMS in change control,
- SOP management requirements
- Implementation of EU Variation Regulation ,
- The advantages of handling GxP documentation by means of EDMS,
- ....
May 20, 2010 - Regulatory Affairs / eCTD
- The principles of the new Variation regulation ,
- eCTD – European standard or unbinding guideline?
- Implementation of the eCTD at the agency, results of the eCTD pilot concerning validation, baseline submissions and hyperlinking,
- How to handle grouping and worksharing in eCTD? ,
- ...
Price Information:
Participation on Conference is FREE of charge, registration however is required. Conference participants are responsible for the arrangement and payment of their own travel and accommodation.
How to Register:
Follow the link to Online Registration or fill in Registration form and fax it to +386 07 393 06 20.
For any further informations please contact Ms. Marjeta Kocjan (+386 7 393 06 00), send us an email: marjeta.kocjan@infotehna.com.