Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement

Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement is a webinar that covers topics such as:

  • System Development Life Cycle (SDLC) Methodology
  • Computer System Validation (CSV)
  • 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
  • "GxP" - Good Manufacturing, Laboratory and Clinical Practices (GMPs, GLPs, GCPs)
  • Validation Strategy/Planning that will take into account the system risk assessment and system categorization (GAMP V) processes
  • Data Retention/Archival to ensure security, integrity and compliance
  • Critical Training and Organizational Change Management (OCM)
  • Policies and Procedures
  • FDA Response to Change
  • FDA Regulatory Trends
  • Recent trends in technology that need to be addressed in the CSV approach
  • Recent FDA findings for companies in regulated industries
  • Industry Best Practices

Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement is intended for:

  • Information Technology Managers
  • Information Technology Analysts
  • QC/QA Analysts
  • QC/QA Managers
  • Clinical Data Scientists
  • Clinical Data Managers
  • Compliance Managers
  • Analytical Chemists
  • Automation Analysts
  • Laboratory Managers
  • Manufacturing Supervisors
  • Manufacturing Managers
  • Computer System Validation Specialists
  • Supply Chain Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • GMP Training Specialists
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Past Events

Find Similar Events by Category