21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 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 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

   21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2018  18-19 Oct 2018, Richmond, United States (77461)
   21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2018  13-14 Sep 2018, San Diego, United States (76687)

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