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Preparing For Fda Pre-approval Inspections

RRP $345.99

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This Second Edition is an essential guide to preparing for FDA pre-approval inspectionsa "taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.

Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition:

  • chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections
  • demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors
  • focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility


The Necessary King

RRP $376.99

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The Necessary King explains why Israel needed a king according to the Deuteronomistic History, and why its exilic readers can expect no future except under Davidic rule. Given Israel's tendency to rebellion against its divine suzerain, the king is the necessary agent of God's colonization of Israel, making and keeping it a loyal subject. The Deuteronomistic History with its pro-Davidic narrative has three prongs, each of which relies on an imitation of the imperial ideology of Judah's colonial masters. First, Dtr imitates the discourse of Neo-Assyrian treaties and Mesopotamian royal inscriptions, replacing the imperial suzerain with God. Second, having established this client-suzerain relationship in Deuteronomy, Dtr then goes on to imitate imperial portrayals of the disloyal and wicked foreign enemies whom the Mesopotamian king colonizes. Israel is a foreign enemy in God's eyes, repetitively proving their disloyalty to their divine suzerain and so demonstrating the need for an Israelite king who will colonize them-for their own good. Third, Dtr imitates the ideology of the Mesopotamian powers in its portrayal of the monarchy. Dtr presents the Davidides' relation to Judah/Israel just as the Mesopotamian colonial powers present their kings' relation to the foreign peoples they have conquered: their colonial rule is necessary, and actually benefits the peoples whom they colonize. Disqualifying prophets, priests, and judges as potential leaders of Israel, and presenting the people as far too sinful to live without leadership, the Deuteronomistic History portrays the Davidic monarchy as a necessity.



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Smart Move Inspections Articles

Purchase Inspection Home Inspector Home Inspections Inspect Home
Masonry Inspection Termite Inspector Inspect Chimney Construction Inspections
Estate Inspection Inspection Necessary Pest Inspection Termite Inspect

Smart Move Inspections Books

Purchase Inspection Home Inspector Home Inspections Inspect Home
Masonry Inspection Termite Inspector Inspect Chimney Construction Inspections
Estate Inspection Inspection Necessary Pest Inspection Termite Inspect

Smart Move Inspections





imageedit_5_3949838586

Website Investments