FDA Compliance and GAMP V Computer System Classification 2016

Key Topics

• Develop the ability to apply GAMP V in classifying computer systems in your organization
• GAMP V computer system classifications
• Best practices necessary to ensure all systems are classified properly and validated appropriately
• The level of computer system validation required, based on the classification as determined using GAMP V
• How to effectively document the process of computer system classification and how to maintain current information about the various systems in your organization and how they are validated
• How to develop the appropriate computer validation strategy, including the level of testing required for the given computer system classification, as determined by GAMP V
• The level of training required for the various GAMP V computer system classifications, and the skills and expertise necessary to make the classification determination
• How to gain information about trends in validation, as industry progresses and new best practices emerge

Who should Attend

Senior attendees involved or interested in:

• QC/QA Managers and Analysts
• Information Technology Analysts
• Analytical Chemists
• Clinical Data Managers and Scientists
• Lab Managers
• Compliance Managers
• Computer System Validation Specialists
• Automation Analysts
• Business stakeholders and individuals who are responsible for CSV planning, execution, reporting, compliance, and audit
• GMP Training Specialists
• Consultants