FDA
Showing 17–32 of 81 results
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Quality Risk Management Post ICH GCP E6 R2 Addendum
$279.00 – $2,550.00 Select options -
Environmental Monitoring (EM) – Establishing and Improving Programs Using a Risk-based Approach
$279.00 – $2,550.00 Select options -
Cell Therapy: Process Design Considerations To Support Commercialization
$279.00 – $2,550.00 Select options -
Quality Assurance and Quality Control – Differences in FDA vs. EU Regulations
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FDA’s New Guidance on Comparability Protocols: What You Need to Know
$279.00 – $2,550.00 Select options -
FDA’s Final Guidance On Method Development And Validation – What You Must Know
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Top IND Pitfalls & How to Avoid Them
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Got a Date with the FDA? Conducting Successful Meetings
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The Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown
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Medical Device Recalls – Keys To Implementing A Successful Approach
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Monitoring Electronic Health Records (EHRs): Frequently Asked Questions – Understanding the Recent May 2016 FDA Draft Guidance
$279.00 – $2,550.00 Select options -
HIPAA & Source Data Access: Dispelling the Myths
$279.00 – $2,550.00 Select options -
FINAL Risk-based Monitoring Guidance: Updates, Impact & Analysis on Clinical Monitoring Systems
$279.00 – $2,550.00 Select options -
NEW FDA Data Integrity Draft Guidance – Key Points to Understand
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Regulatory GCP Inspections: Preparation, Participation & Follow-up
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Applying Quality Risk Management (QRM) in Manufacturing – A Proactive Approach
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