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Statistical Elements of Implementing ICH Quality Guidelines
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Statistical Elements of Implementing ICH Quality Guidelines

  • Elaine Eisenbeisz,
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx
FDA Compliance and Clinical Trial Computer System Validation
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FDA Compliance and Clinical Trial Computer System Validation

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Equipment and Utilities Qualification
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Equipment and Utilities Qualification

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Lead Auditor EN ISO 13485:2021 and EU MDR 2017/745 - Regulation
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Lead Auditor EN ISO 13485:2021 and EU MDR 2017/745 - Regulation

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HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
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HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer

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Medical Device Quality Systems, Quality System Regulations, and CAPA
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Medical Device Quality Systems, Quality System Regulations, and CAPA

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How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV?
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How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV?

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Statistics for Process Control
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Statistics for Process Control

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Clinical Data Management (CDM)
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Clinical Data Management (CDM)

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REACH and RoHS Compliance: Gain a Deeper Understanding
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REACH and RoHS Compliance: Gain a Deeper Understanding

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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

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Risk Management System in Medical Devices Industry
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Risk Management System in Medical Devices Industry

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Social Media Crisis Management
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Social Media Crisis Management

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Biocompatibility Testing for Medical Devices
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Biocompatibility Testing for Medical Devices

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Statistical Techniques for Medical Devices and Diagnostics
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Statistical Techniques for Medical Devices and Diagnostics

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Recordkeeping and Documentation in a GLP Laboratory (US FDA, US EPA and OSHA Focus)
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Recordkeeping and Documentation in a GLP Laboratory (US FDA, US EPA and OSHA Focus)

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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada

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Design Control Essentials for Medical Devices
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Design Control Essentials for Medical Devices

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The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products
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The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products

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Effective Technical Writing in the Life Sciences
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Effective Technical Writing in the Life Sciences

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