Webinar on Clinical IT Inspection Readiness

Description :

All Regulatory Agencies are entitled to come in to any company involved in clinical trials and review documentation supporting procedures and computerized systems, in as part of an Inspection. The most common regulations that will form the back-ground to an inspection with regards to Clinical Trials, are those released by ICH and FDA. The aspects of a company that need attention in the run up to an inspection are the documentation related to people and their roles, responsibilities and training; procedures their current versions, approval signatories and related dates and computerized systems utilized within the trial processes, and all the documentation that supports their validated state.

This course provides an understanding of the various activities that need to be completed in preparation for a Regulatory Inspection targeting one of the computerized systems that were utilized during a clinical trial. It is vital to prepare adequately for a regulatory inspection to limit the findings documented by the inspectors.

Areas Covered in the Session :

What happens during an inspection?

The component parts of an IT system

Regulatory Inspection expectations and examples of findings

Overview of Computer System Validation

Good Document Practice including archiving

Inspection preparation

Inspection behaviours

Who Will Benefit:

Quality Assurance Teams

Trial Management Teams

Data management Teams

Clinical Research Associates

Project Managers

IT staff who may be called upon as System Owners or Programmers

Clinical Trial Data Trainers

Clinical Trial Data Managers

Documentation Teams

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1850