21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits October 2012

  • 02 Oct 2012
  • Webinar

Description

21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits is a webinar that covers topics such as:

  • Regulations meaning
  • Data and systems relevant to the regulations
  • Regulatory requirements of Part 11 compliance: software product features, SOPs and validation documentation
  • And warning Letters avoidance
  • Current computer system industry standards for data transfer, security and audit trails
  • Security, data integrity and protection
  • Regulatory requirements related to computer system standards for data transfer, security, electronic signatures, audit trails, biometric signatures and digital pens
  • Digital pens, Electronic signatures and biometric signatures
  • Product features to look for when purchasing COTS software
  • SOPs required for the IT infrastructure
  • Validation resources reduction by using easy to understand fill-in-the-blank validation documents

21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits is recommended for:

  • QA
  • IT
  • Laboratory Staff
  • QC
  • GMP, GCP, GLP professionals
  • Managers

Past Events

Important

Please, check "21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Medical laboratories, Medical technology
Technology: Information Technology (IT), IT Security, Software engineering

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