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Accelerating-Generic-Drug-Development

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

$397.00
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval. Read More

Drug Books

Drugmaker’s Guide to Process Validation: Principles, Methods and Compliance

Drugmaker’s Guide to Process Validation: Principles, Methods and Compliance

$397.00
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The Preapproval Inspection

The Preapproval Inspection: Passing the FDA’s GMP Test

$397.00
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Quality Risk Management in the EU

Quality Risk Management in the EU: Concepts and Compliance

$397.00
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Data Integrity for Drug and Device Manufacturers

Data Integrity for Drug and Device Manufacturers: Avoiding Breaches and Closing Gaps

$397.00
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Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

$397.00
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GMP Inspection in the EU

GMP Inspection in the EU: Avoiding 12 Common Pitfalls

$397.00
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Pharmaceutical Quality Risk Management

Pharmaceutical Quality Risk Management: Navigating New Regulatory Requirements

$397.00
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Supplier-Management-for-Drugmakers-500.jpg

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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