Research & Development
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Implementing a Robust Change Control Program – Key Elements for Process and Documentation ComplianceKelly ThomasOn-Demand00
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Measuring Medical Affairs Success – Identifying the Key Performance Indicators (KPIs) for Successful TeamsNatalee KestlerOn-Demand10
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Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAsPenelope Przekop, MSQA, RQAP-GCPOn-Demand00
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The EU General Data Protection Regulation (GDPR): What US Pharma/Biotech Companies Need to Know to ComplyPenelope Przekop, MSQA, RQAP-GCPOn-Demand00
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Executing Proper Event Investigations: Critical Steps In Ensuring Compliant Corrective ActionsJudy Carmody, Ph.D.On-Demand00
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Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It WorksJoanna GallantOn-Demand00
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Biocontainment For Manufacturing: Understanding The Risks, Guidance, and Design RequirementsErich Bozenhardt, Herman BozenhardtOn-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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Right to Try Legislation: Impact on Industry, Health Authorities, and PatientsMichael PierroOn-Demand00
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Building a Best in Class Medical Affairs Organization: Strategies for SuccessJudith SerafinOn-Demand10
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FDA Regulations for Analytical Instrument Qualification and Validation: Comprehensive Best PracticesJoy McElroyOn-Demand10