Remote Inspection Training

February 23-24, 2022

Interactive Training to Prepare and Adapt Your Inspection Preparation

Brochure Register

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

This training course is designed for anyone involved in a clinical inspection with regulatory authorities, including:
  • 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