Ensuring Integrity and Security of Electronic Records for FDA Compliance 2012

  • 28 Nov 2012
  • Webinar

Description

Ensuring Integrity and Security of Electronic Records for FDA Compliance 2012 is a webinar that covers topics such as:

  • How FDA inspectors check integrity and security of data
  • Eight key FDA/EU requirements for integrity and security of electronic data
  • The importance of limited access to `individual users` rather than to groups
  • Most frequent security and integrity issues: going through recent 483`s, EIRs and warning letters?
  • Critical integrity and security issues during the entire life of data: from data acquisition through evaluation to archiving
  • FDA compliant definition, acquisition, maintenance and archiving of raw data
  • Documenting changes of data: paper, hybrid systems, electronic
  • Examples how to ensure and document data integrity
  • Review of electronic audit trail: who, what, when and how
  • The importance of electronic audit trail to document data integrity
  • Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
  • Ensuring timely availability through validated back-up and archiving

Ensuring Integrity and Security of Electronic Records for FDA Compliance 2012 brings together:

  • QA Managers and Personnel
  • IT Managers and System Administrators
  • Regulatory Affairs
  • QC and Lab Managers
  • Documentation Department
  • Training Departments
  • Consultants

Past Events

Important

Please, check "Ensuring Integrity and Security of Electronic Records for FDA Compliance" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical technology, Pharma

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