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Featured Product In Books

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Calculating Sample Size to Satisfy FDA Expectations

$199.00
Regulatory authorities require risk-based sample sizes that have a sound statistical foundation. Ensure your organization can meet their expectations with Calculating Sample Size to Satisfy FDA Expectations. Read More

Books

New Adverse Event Reporting Procedures

New Adverse Event Reporting Procedures: A Devicemaker’s Guide to the IMDRF Code Transition

$249.00
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Pharmaceutical Quality Risk Management

Pharmaceutical Quality Risk Management: Navigating New Regulatory Requirements

$249.00
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Devicemaker’s Guide to EU-MDR

Devicemaker’s Guide to EU-MDR: 71 Worksheets for Manufacturing Compliance

$229.00
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Supplier Management for Devicemakers

Supplier Management for Devicemakers: Qualification, Contracts and Audits

$149.00
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Supplier Management for Drugmakers: Qualification, Contracts and Audits

$149.00
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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

$129.00
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Risk Management for Devicemakers

Risk Management for Devicemakers: New Requirements in ISO 14971

$129.00
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Evolving Quality Management Regulations

Evolving Quality Management Regulations: A Devicemaker’s Guide

$229.00
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Postmarket Surveillance Under EU-MDR

Postmarket Surveillance Under EU-MDR: Preparing for New Requirements

$397.00
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Preparing for the EU-MDR Audit

Preparing for the EU-MDR Audit: Understanding New Requirements and Processes

$99.00
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Core Processes in the Pharmaceutical Laboratory

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

$99.00
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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

$249.00
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