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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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UDI Direct Marking for FDA Compliance: Navigating New Rules

$197.00
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Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best

$397.00
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The Fast Track to Drug Approval: Five FDA Pathways for Expedited Review

$397.00
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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

$397.00
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CDRH Reorganized: New Strategies for Devicemakers

$397.00
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Regenerative Medicine: Steps to Accelerate Development

$397.00
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Quality Management Essentials: Expert Advice on Building a Compliant System

$397.00
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Medical Device Calibration: A Step-by-Step Guide to Meeting FDA and ISO Standards

$197.00
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Risk Management in Clinical Trials: The New ICH E6 Focus

$397.00
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Guide to FDA Drug Safety Regulation, 2018 Edition

$397.00
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510(k) Change Analysis: Complying with FDA’s Final Guidances

$197.00
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Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices

$397.00
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