Validation of FDA-Regulated Computer Systems 2018

Topics

• System Development Life Cycle (SDLC) Methodology
• Computer System Validation (CSV)
• Validation Planning
• Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice, Good Clinical Practice (GCP)
• Risk Assessment
• GAMP 5 System Classification
• Configuration and Custom Coded Solutions
• Functional Requirements Specification
• Operational Qualification (OQ) Testing
• Installation Qualification (IQ) Testing
• Validation Summary Report
• Performance Qualification (PQ) Testing (User Acceptance Testing/UAT)
• Policies and Procedures
• Operational Maintenance for Validated Systems
• Organizational Change Management (OCM)
• Training
• Disaster Recovery and Business Continuity Planning
• Periodic System Review
• System Retirement

Who should Attend

• IT Developers
• Information Technology (IT) Analysts
• QC/QA Managers and Analysts
• IT Support Staff
• Compliance Managers and Auditors
• Clinical Data Managers and Scientists
• Computer System Validation Specialists
• Lab Managers and Analysts
• Business Stakeholders using Computer Systems regulated by FDA
• GMP Training Specialists
• Consultants in the Life Sciences and Tobacco Industries
• Regulatory Affairs Personnel
• College students attending schools and studying
• Interns working at the companies listed above
• Computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements