GCP
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It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020Sandra “SAM” SatherOn-Demand00
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Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk MitigationSandra “SAM” SatherOn-Demand00
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Conducting a Virtual GCP Audit of a CRO Managed Study During the COVID-19 PandemicMichael PierroOn-Demand00
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Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAsPenelope Przekop, MSQA, RQAP-GCPOn-Demand00
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Note to File 101: Critical Steps for When, and When Not To, Engage in NTFsLuisa Monica, Jackie MorrillOn-Demand00
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Conducting an Effective GCP Audit of a CRO-Managed Ongoing Study: Tips and SuggestionsMichael PierroOn-Demand00
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Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand00
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CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand00
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