• Basics of computer validation
• Regulations applicable to computer systems validation
• How to plan computer systems validation for the system’s lifecycle
• Developing an organization’s own system versus purchasing a system
• Differences in internal versus vendor audits

• Computer system uses
• Auditors
• Quality assurance professionals
• Regulatory affairs professionals
• Information technology professionals

Participants who complete this training should be able to:

• Contribute positively to a project
• Validate a computer system
• Manage a computer systems validation project
• Use computer systems validation procedures within your organization
• Implement quality and risk procedures into computer systems used in your organization