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FDAnews offers an Online Books Library Subscription for year-round unrestricted access to all books and reports. They can be accessed, searched, downloaded and read on laptops and other mobile devices anywhere, anytime!

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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

Books

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls

$177.00
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Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

$397.00
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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

$230.00
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Biological Risk Evaluation and Management for Medical Devices

Biological Risk Evaluation and Management for Medical Devices

$397.00
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Drugmaker’s Guide to ASTM E2500: Best Practices

Drugmaker’s Guide to ASTM E2500: Best Practices for Increasing Process Efficiency and…

$397.00
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Device Accessories: Understanding and Implementing FDA’s Guidance

Device Accessories: Understanding and Implementing FDA’s Guidance

$177.00
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Hack-Proofing Medical Devices: Ensuring Product Safety through Cybersecurity

Hack-Proofing Medical Devices: Ensuring Product Safety through Cybersecurity

$397.00
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Dealing with China’s Regulatory Authorities

Dealing with China’s Regulatory Authorities: Tips for Devicemakers

$177.00
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Drug or Device? How the 21st Century Cures Act Impacts Combination Products

Drug or Device? How the 21st Century Cures Act Impacts Combination Products

$397.00
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Understanding the New EU Medical Device Regulations

Understanding the New EU Medical Device Regulations

$397.00
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Internal Auditing Basics: A Guide for Drug and Device Manufacturers

Internal Auditing Basics: A Guide for Drug and Device Manufacturers

$177.00
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Guide to FDA and EU Medical Device Regulations, 2017 Edition

Guide to FDA and EU Medical Device Regulations, 2017 Edition

$397.00
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