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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

$230.00
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing. Read More

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Achieving ANDA Success: Working with the FDA to Win First-Cycle Approval

$397.00
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Medical Device Inspections Guide

$377.00
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Navigating Off-Label Device Promotion: How Will the FDA Settlements Impact Devicemakers?

$397.00
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Off-Label Drug Promotion after Amarin: What Does the FDA Settlement Mean?

$397.00
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Managing Nonconforming Product: A Devicemaker’s Guide to Compliance

$397.00
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Obtaining Consent in International Clinical Research: Key Considerations

$397.00
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Pharmacovigilance in the European Union: A Guide to New Directives

$397.00
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Global Supply Chain Management for Drugmakers

$397.00
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Choosing the Best Device Sample Size for Verification and Validation

$397.00
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Root Cause Analysis for Drugs and Devices

$397.00
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Japan’s New Fast Track Pathway for Drugmakers

$397.00
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Mastering the FDA's Import Rules

$397.00
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