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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

Drug Books

New Inspection Models

New Inspection Models: Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid?

$397.00
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Protecting the Pharma Supply Chain: FDA Efforts at Global Harmonization

Protecting the Pharma Supply Chain: FDA Efforts at Global Harmonization

$397.00
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Auditing Contractors and Suppliers

Auditing Contractors and Suppliers: A Guide for Drugmakers

$397.00
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Guide to Safety Reporting for Drugmakers

Guide to Safety Reporting for Drugmakers: FDA Adverse Event Requirements

$397.00
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Risk-Based Supplier Qualification

Risk-Based Supplier Qualification: Finding the Right Vendors for the Most Critical Supplies

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

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

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The Preapproval Inspection

The Preapproval Inspection: Passing the FDA’s GMP Test

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Quality Risk Management in the EU

Quality Risk Management in the EU: Concepts and Compliance

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Data Integrity for Drug and Device Manufacturers

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

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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

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GMP Inspection in the EU

GMP Inspection in the EU: Avoiding 12 Common Pitfalls

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Pharmaceutical Quality Risk Management

Pharmaceutical Quality Risk Management: Navigating New Regulatory Requirements

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