21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2017

  • 09-10 Nov 2017
  • Four Points by Sheraton Los Angeles International Airport, CA, United States

Description

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2017 is a conference that 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)
  • 21 CFR Part 11
  • Security, Access, Change Control and Audit Trail

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2017 is intended for:

  • 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
  • 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

Health & Medicine: Medical device, Medical laboratories, Pharma
Industry: Food & Beverages
Science: Laboratories
Technology: Information Technology (IT)

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