Course - Berlin, Germany
Transferring an analytical method from one laboratory to another should be straightforward but unfortunately it is a process which is often problematic. Recognition of this has resulted in a new USP chapter <1224> and an update to chapter 6 of the EU GMP regulations. In this one day course the different approaches to transfer are explored fully and case studies are used extensively to follow the process from review of the method prior to transfer, to creating a suitable protocol with relevant acceptance criteria, and evaluating the results generated to assess whether the transfer has been successful.
Anyone involved in the transfer of analytical methods. For example: Analytical chemists, laboratory managers/supervisors, quality control analysts/managers, quality assurance managers, and regulatory affairs managers.
Please note: Familiarity with the characteristics studied during analytical method validation is necessary for this course since these are used for method transfer. The course, Validation of Analytical Methods for Pharmaceutical Analysis, is recommended.
Wed, May 08, 2013 - Wed, May 08, 2013
Steigenberger Hotel Berlin, Berlin, Germany
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