In-Depth Computer System Validation (CSV) for FDA Compliance 2019

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
• FDA Recent Inspection Trends and Key Areas of Focus
• 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 Computer System Validation, Regulatory Affairs/matters (related to FDA)
• Interns Working at the Companies Listed Above