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hello everyone my name is rachel sullivan im a tmp inspector ive been in this role to hate at the hra for six years now today ill be talking to you about the management of outsource activities and qp responsibilities in this regard the primary focus of this presentation will be the management of outsourced manufacturing and testing series however i will touch on certain aspects of management of outsourced service providers also and the guidance on this topic is well established to our resolution 18s presentation uh on deficiencies in the last number of years we have seen an increase in deficiencies being cited in this area also at the increase in the number of virtual bacterication sites being established and in general an increase in outsourced manufacturing testing and lighter brexit without the talk and this topic today would be beneficial some way talk is going to cover the following background assessment of contract sectors prior to outsourcing contracts quality contract and q