21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

Description

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.

Future Events

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2020

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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