Auditing IT Systems for Regulatory Compliance 2018

Auditing IT Systems for Regulatory Compliance 2018 is a seminar dedicated to regulatory requirements and expectations, and tools for the auditor to ensure the integrity.

Topics

• The details of electronic data and records
• The requirements and expectations by regulators in the medical device, pharmaceutical, and food industries
• Risk-based methodology to the audit process
• Approach to performing a quality audit of a regulated IT system
• Regulated IT system’s validation
• Practical methods for evaluating controls to be placed on suppliers of IT systems and services
• How to write audit findings for regulated IT systems
• How to evaluate a system’s operational usage

Who should Attend

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