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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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Drugmaker’s Guide to the 21st Century Cures Act: Changing the Face of Pharmaceutical and Biologics Regulation

$397.00
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Devicemaker’s Guide to the 21st Century Cures Act: Changing the Face of Medical Device Regulation

$397.00
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Navigating China’s Medical Device Regulations

$397.00
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Corrections, Removals and Recalls: A Guide for Devicemakers

$177.00
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Clinical Trial Compliance Guide: FDA Requirements

$397.00
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Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices

$397.00
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Device Documentation: A Guide to Managing Four Critical Production Files

$177.00
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Human Subjects Questions, FDA Answers

$397.00
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Three Phases of QSR-Compliant Equipment Control

$177.00
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Clinical Investigator Questions, FDA Answers

$397.00
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Special Protocol Assessment: Winning FDA Support for Trial Design

$397.00
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20 Elements of Postmarket Reporting: Building Periodic Benefit-Risk Evaluation Reports

$177.00
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