21 CFR Part 11 and Annex 11 Compliance - specifics needed to eliminate 483s 2015

  • 22 Jan 2015
  • Webinar

Description

21 CFR Part 11 and Annex 11 Compliance - specifics needed to eliminate 483s 2015 is a webinar dedicated to

  • What Part 11 means
  • Data and systems are subject to Part 11
  • Three primary areas of Part 11 compliance: software product features, SOPs and validation documentation
  • Avoid 483 and Warning Letters
  • The computer system industry standards for data transfer, security and audit trails
  • Security, data integrity and d protect intellectual property
  • SOPs required for the IT infrastructure
  • Digital pens, Electronic signatures and biometric signatures
  • Product features for COTS software


21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s brings together IT, Computer System users, Managers, QA and Executives.

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Important

Please, check "21 CFR Part 11 and Annex 11 Compliance - specifics needed to eliminate 483s" official website for possible changes, before making any traveling arrangements

Event Categories

Science: Life Sciences & Biology
Technology: Data management, Information Technology (IT), IT Security

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