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FDA’s Alternative Inspection Tools

FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

$397.00
If you want to pass your next inspection, FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions is a must. Read More

Drug Books

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Supplier Management for Drugmakers: Qualification, Contracts and Audits

$397.00
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Company Core Data Sheets and Benefit-Risk Evaluations

Company Core Data Sheets and Benefit-Risk Evaluations: A Drugmaker’s Guide to Postmarket Safety Reporting

$397.00
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Core Processes in the Pharmaceutical Laboratory

Core Processes in the Pharmaceutical Laboratory: EU GMP-Compliant Sampling and Handling of Substances

$130.00
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Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes

Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes

$397.00
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Auditing for Quality Manufacturing

Auditing for Quality Manufacturing: Five Areas of Risk for Drug and Device Manufacturers

$397.00
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The Road to a Pharmaceutical Quality System in the EU

The Road to a Pharmaceutical Quality System in the EU

$100.00
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The Revised ICH E8: A Guide to New Clinical Trial Requirements

The Revised ICH E8: A Guide to New Clinical Trial Requirements

$397.00
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Managing Data and Documentation for FDA Inspections

Managing Data and Documentation for FDA Inspections

$397.00
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EU-Compliant Batch

EU-Compliant Batch Release of Medicinal Products: How to Meet the Requirements of Annex 16 of the EU…

$135.00
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IOM-IMAGECOVER

Investigations Operations Manual 2019

$377.00
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Accelerating-Generic-Drug-Development

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

$397.00
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Surviving the New FDA Inspection Plan

Surviving the New FDA Inspection Plan: A Drugmaker’s Guide to Working with the Agency

$497.00
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