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Virtual Training Course (US Eastern Time)

Aug 10, 2020 9:00 AM - Aug 13, 2020 1:15 PM

The Pharmacovigilance Quality Management System

In this virtual training course, learn how to design, develop, and manage a quality system related to your pharmacovigilance system.

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Session 14: Pharmacovigilance Inspections and Inspection Readiness

Session Chair(s)

Yvonne Ditoro, BSN, MBA, RN

Yvonne Ditoro, BSN, MBA, RN

Pharmacovigilance Operations Consultant

Yvonne Ditoro and Associates LLC, United States

  • The types and scopes of pharmacovigilance inspections
  • The role of the PSMF in ensuring Marketing Authorization Holders and pharmacovigilance units remain inspection ready
  • How to prepare for inspections and be inspection ready
  • Checklists for planned and unplanned inspections, and tips on being the interviewee
  • Exercise: Each participant will write on a Zoom whiteboard, one test question related to Session 14

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