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Typcal project management would include the technolgy transfer of a drug substance from one manufacturing site to another, and would include providing regulatory support for FDA notification and approval.Projects requiring the validation of computer systems and data bases to meet cGMP requirements have also been accomplished. International outsourcing would be demonstrated by identifying sources of active Pharmaceutical Ingredients in China India and Europe that can contract manufacture for US companies. Training activities include all aspects of FDA cGMP compliance training, regulatory filings and process inprovement techniques including statistical analysis of process data

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$65/hr Ongoing

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Typcal project management would include the technolgy transfer of a drug substance from one manufacturing site to another, and would include providing regulatory support for FDA notification and approval.Projects requiring the validation of computer systems and data bases to meet cGMP requirements have also been accomplished. International outsourcing would be demonstrated by identifying sources of active Pharmaceutical Ingredients in China India and Europe that can contract manufacture for US companies. Training activities include all aspects of FDA cGMP compliance training, regulatory filings and process inprovement techniques including statistical analysis of process data

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AnalysisCompliance TrainingInternationalInternational OutsourcingManagementOutsourcingProject ManagementReviewsTraining

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