15. - 16.03.2012

Vienna: Handling Changes and Variations

In this two days conference, Dr. Hiltrud Horn will give presentations on how to deal with manufacturing process changes and with packaging changes. Furthermore, detailed insight will be provided on dealing with variation procedures.

For more information please visit the following website:
http://www.gmp-navigator.com/daten/training/ECA_HandlingChangesVariations_2012.pdf

(Conference organized by Concept Heidelberg)



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EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.

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  • 13. - 14.03.2012
    Berlin: Change Control – New Aspects and Best Practices
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  • 15. - 16.03.2012
    Vienna: Handling Changes and Variations
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