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"It is also important to monitor and oversee your partners....It
is your responsibility to make sure that your outsourcing partners are performing in compliance with those standards."
"...you
may audit once a year for your own operations, but you may audit two or three times a year for an outsourced operation, especially
a critical one."
"In an outsourced environment, you need to do audits more frequently because you have less control
over exactly what's going on and less knowledge of it."
"The FDA has established requirements for conducting those
kinds of audits so that the people who conduct them are not to be the same people for the issues audited. That can be a problem,
especially in smaller companies where you have very limited resources and personnel."
"Do not outsource activities
that you cannot monitor."
"You will need to monitor those things to make sure that your vendors are doing those
properly."
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