Auditing IT Systems for Regulatory Compliance

Date	Aug 23, 2018
Time	11:00 AM EDT
Cost	$87249.50
Online

This course provides practical information on the methods and techniques for conducting an audit of regulated IT systems in order to ensure the system is compliant with regulatory requirements and expectations. These systems include those used in the company’s Quality Management System for development, manufacture, and support of medical device, pharmaceutical, and nutritional products. The course covers regulatory requirements and expectations, and provides tools for the auditor to ensure the integrity of electronic records. It develops a risk-based framework for the quality auditor to evaluate regulated IT systems from the perspective of the business operations and the risks to those operations and the critical data associated with the products.

Learning Objectives:
By the end of the course, you will:

• Understand the requirements and expectations by regulators in the medical device, pharmaceutical, and food industries
• Understand the details of electronic data and records
• Develop an approach to performing a quality audit of a regulated IT system
• Apply a risk-based methodology to the audit process
• Develop practical methods for evaluating controls to be placed on suppliers of IT systems and services
• Be able to evaluate a regulated IT system’s validation
• Understand how to evaluate a system’s operational usage
• Know how to write audit findings for regulated IT systems

Who Should Attend :

• Quality Departments
• IT Departments
• Validation Teams
• Quality Auditors
• Audit Management
• IT Technical staff who specify or develop the systems
• Business process owners whose processes are supported by the systems
• System owners who are responsible for the systems