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Now that Risk-MaPP has become accepted by drug regulatory agencies, companies that wish to operate according to the Guide’s prescription for a health-based approach to cleaning validation must present full justification and documentation for the Acceptable Daily Exposures (ADEs) they develop. This webinar will teach participants how to develop an ADE monograph that will pass muster with regulatory agencies. Documentation should include the background and purpose of the document, sources of data, key data element summaries, and a detailed explanation of how the ADE value was derived.
$ 49.00 / € 45.00
Non Member Price:
$ 149.00 / € 136.00