Remote Inspection Training
February 23-24, 2022
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
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