FDA
Showing 49–64 of 81 results
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Understanding & Implementing The Revised NIH & FDA Clinical Trial Protocol Template
$279.00 – $2,550.00 Select options -
Good Clinical Practices (GCP) Overview for Clinical Research Professionals – A Global Primer
$149.00 – $1,360.00 Select options -
Clinical Study Requirements – Understanding Differences Between the US and EU
$279.00 – $2,550.00 Select options -
Responding Effectively To FDA Form 483 Observations – Strategies To Ensure Compliance
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FDA Inspection Readiness – A Compliance Primer
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Computerized Systems and Data Integrity – Avoiding The Top Five Regulatory Pitfalls
$279.00 – $2,550.00 Select options -
ANDAs: FDA Guidance on Stability Testing of Generic Products
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Stability Programs – Key Factors in Meeting FDA/ICH Expectations
$279.00 – $2,550.00 Select options -
Medical Device Complaint Handling and MDR Reporting
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Preparing Personnel to Interact with Regulatory Inspectors
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Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers
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The Premarket Notification/510k Submission: Using Substantial Equivalence to your Advantage!
$279.00 – $2,550.00 Select options -
Reprocessing Medical Devices: Final Guidance – How To Meet New Validation Requirements
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Design Controls 101: Beyond Regulatory Requirements
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Communication With FDA: What Do We Say And How Do We Say It?
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FDA Quality Metrics Draft Guidance: What You Need to Know to be Prepared for Implementation
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