21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2018

  • 18-19 Oct 2018
  • Courtyard by Marriott Richmond Downtown, VA, United States

Description

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2018 covers topics such as:

  • System Development Life Cycle (SDLC) Methodology
  • Computer System Validation (CSV)
  • Validation Strategy
  • Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • GAMP 5 "V" Model
  • System Risk Assessment
  • Electronic Records/Electronic Signatures (ER/ES)
  • CFR Part 11
  • Policies and Procedures
  • Security, Access, Change Control and Audit Trail
  • Industry Best Practices and Common Pitfalls
  • Training and Organizational Change Management

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2018 brings together:

  • Information Technology Developers and Testers
  • Information Technology Analysts
  • Clinical Data Managers and Scientists
  • QC/QA Managers and Analysts
  • Laboratory Managers
  • Analytical Chemists
  • Manufacturing and Supply Chain Managers and Analysts
  • Automation Analysts
  • GMP Training Specialists
  • Computer System Validation Specialists
  • Business System/Application Testers in FDA-Regulated Functional Areas
  • Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas
  • This seminar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.

Past Events

Important

Please, check "21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance
Government & Global Issues: Law & Regulations
Technology: Information Technology (IT)

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