Regulatory & Compliance
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Environmental Monitoring (EM) – Establishing and Improving Programs Using a Risk-based ApproachKelly ThomasOn-Demand00
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Cell Therapy: Process Design Considerations To Support CommercializationErich Bozenhardt, Herman BozenhardtOn-Demand00
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Quality Assurance and Quality Control – Differences in FDA vs. EU RegulationsThomas PritchettOn-demand00
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FDA’s Final Guidance On Method Development And Validation – What You Must KnowThomas PritchettOn-demand00
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The Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance BreakdownRita HoffmanOn-Demand00
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Monitoring Electronic Health Records (EHRs): Frequently Asked Questions – Understanding the Recent May 2016 FDA Draft GuidanceSandra “SAM” SatherOn-demand00
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Good Documentation Practices for Clinical Trials – Ensuring Air-Tight ResultsSandra “SAM” SatherOn-demand00
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