Remote Inspection Training

JANUARY 21–22, 2021

Interactive Training to Prepare and Adapt Your Inspection Preparation

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Quick Overview

Attendee will be provided with an overview of how to adapt their inspection readiness plan to ensure they are prepared for a remote inspection.

Who Should Attend

  • Clinical Compliance and Quality Management professionals
  • Inspection Readiness professionals
  • Clinical Operation Managers
  • Quality Assurance professionals
  • TMF Managers
  • Regulatory Affairs

Key Learning Objectives

  • Purpose of Inspections; specifically, GCP inspections
  • Different types of inspections; specifically, GCP inspections
  • Review of current Regulatory guidance/blogs regarding remote inspections
  • Preparations for GCP inspections that are impacted when inspection are to be conducted remotely
  • Creation of an inspection readiness plan
  • Appreciate remote mock inspections — goals, objectives, preparations, and CAPAs
  • Preparation of the Trial Master File to play a critical part in successful inspection
  • Preparation activities for remote interviewing by inspectors
  • Consideration of all aspects from a people, process, and systems perspective