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Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
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Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

  • David Nettleton
  • Virtual Seminar | June 14-15, 2023
21 CFR Part 11 Compliance for SaaS/Cloud Applications
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21 CFR Part 11 Compliance for SaaS/Cloud Applications

  • David Nettleton
  • Virtual Seminar | June 14-15, 2023
Statistical Elements of Implementing ICH Quality Guidelines
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Statistical Elements of Implementing ICH Quality Guidelines

  • Elaine Eisenbeisz,
  • Virtual Seminar | Oct 26-27, 2023
Social Media Crisis Management
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Social Media Crisis Management

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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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Biocompatibility Testing for Medical Devices
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Biocompatibility Testing for Medical Devices

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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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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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Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
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Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products

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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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Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
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Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada

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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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The Veterinary Drug Approval Process and FDA Regulatory Oversight
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The Veterinary Drug Approval Process and FDA Regulatory Oversight

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Building a Vendor Qualification Program for FDA Regulated Industries
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Building a Vendor Qualification Program for FDA Regulated Industries

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Statistics for Process Control
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Statistics for Process Control

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Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
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Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

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Designing and Sustaining New and Existing Product Stability Testing Program
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Designing and Sustaining New and Existing Product Stability Testing Program

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