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

In-Depth Computer System Validation (CSV) for FDA Compliance is a webinar that covers topics such as:

  • 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

In-Depth Computer System Validation (CSV) for FDA Compliance is intended for:

  • 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

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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