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CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum
Sandra “SAM” Sather
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ICH E6 Addendum R2 Team Training and Action Planning
Sandra “SAM” Sather
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CRO Oversight Post ICH GCP E6 (R2) Addendum
Sandra “SAM” Sather
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Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum
Sandra “SAM” Sather
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Quality Risk Management Post ICH GCP E6 R2 Addendum
Sandra “SAM” Sather
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Introduction to Biostatistics: 2-Sample Tests and ANOVA
Robert Parody
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Performing Risk Assessment Within GCP
Sandra “SAM” Sather
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Monitoring Informed Consent (IC): Frequently Asked Questions
Sandra “SAM” Sather
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Monitoring Electronic Health Records (EHRs): Frequently Asked Questions – Understanding the Recent May 2016 FDA Draft Guidance
Sandra “SAM” Sather
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