Course No 15551
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DR ANDREW TEASDALE
AstraZeneca, United Kingdom
Free of charge Post Conference Workshop on 17 June 2016:
The Elemental Impurities Database
This Elemental Impurities workshop will examine, through case studies, how a step wise integrated risk-based approach can be taken to the management and control of elemental impurities. As part of this, it will examine the importance of data in such an assessment and potential sources of this data.
This will highlight key initiatives including the establishment of an EI database for excipients.
In connection with this database the following points will be discussed:
I would like to contribute to/send data to the database: What is the procedure?
I would like to get information out of the database: What is the procedure?
What about confidentiality regarding the submission to or reception of information from the database?
It will also examine how risk can be reduced through effective GMP controls established for potential contributory factors such as equipment , water and packaging systems and how this ultimately can lead to a control strategy focused on actual risk and not simply reliant on excessive unfocused testing.