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From GlobalCompliancePanel
Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ... a relatively narrow window of time during which the NDA/ BLA/ ANDA holder can demonstrate to the FDA that the quality systems at the site are in compliance with the GMPs and that appropriate facilities are available to support manufacture of the product. It is therefore important to present the organization in the best light possible. Areas Covered In the Seminar: * Pre-Approval  more...
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tcw11--05/30/12-01:02:32-(462)[B]-[B]-[B]