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Global Vigilance Masterclass: Navigating Safety for Medical Devices & Combination Products

Structured learning across key life sciences areas with real-world applications

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Day 1: Foundations & Regulatory Frameworks

Mastering PV requirements for Devices and Combination products across global jurisdictions.

  • EU MDR/IVDR & FDA 21 CFR Part 803
  • Safety Database Processing
  • Custom Narrative Templates
  • Evaluation Checklists
Compliance & Safety Systems
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Day 2: Risk Management & Strategic Surveillance

Advanced Signal Management and alignment of PSUR/DSUR with Global Risk Management Plans.

  • Signal Management
  • PSUR/DSUR Integration
  • Trackwise/Salesforce Complaint Handling
  • Global Quality Standardization
Risk & Quality Excellence
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Day 3: Operational Execution & Audit Readiness

Strategic management of FSCA and Field Safety Notices with real-world audit simulations.

  • FSCA & Safety Notices
  • Mock Audits & Case Simulations
  • Regulatory-Grade Safety Evaluations
  • Report Drafting Workshop
Audit & Reporting Mastery
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