Data Integrity
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$179
Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk MitigationSandra “SAM” SatherOn-Demand -
$279
Quality Management of Electronic Systems in Clinical Trial Investigations: A Comparison of FDA and EMA GuidanceSandra “SAM” SatherOn-Demand -
$279
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$279
The MHRA Data Integrity Guidance Clarified: What it Means for Industry & PatientsBetsy FallenOn-Demand -
$279
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$279
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$279
The EU General Data Protection Regulation (GDPR): What US Pharma/Biotech Companies Need to Know to ComplyPenelope Przekop, MSQA, RQAP-GCPOn-Demand -
$279
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11Sandra “SAM” SatherOn-Demand -
$279
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$279
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$1199
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$279
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$279
Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand -
$279
CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand
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$279
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$279
Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) AddendumSandra “SAM” SatherOn-Demand