Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts 2015

  • 10 Apr 2015
  • Webinar

Description

Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts 2015 is a webinar that covers topics such as:

  • Computerized System Validation Master Plan
  • Introduction, Historical Perspective, and Definitions
  • Developer Assessment
  • Validation Plan
  • Validation Testing
  • Requirements, Design, and Configuration Specifications
  • Validation Summary Report
  • Procedures/Archival/Traceability
  • System Decommissioning/Retirement
  • Commissioning Memo

Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts 2015 is intended for:

  • Quality assurance staff
  • Project/strategic management
  • Operations staff
  • IT staff
  • Staff members involved with project planning, computerized system validation, system use, validation testing, regulatory compliance of computerized systems and system support

Past Events

Important

Please, check "Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Pharma
Science: Life Sciences & Biology
Technology: Biotechnology

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