CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps 2012

  • 04 Apr 2012
  • Webinar

Description

Topics
  • Dependencies between Predicate rules and Part 11/Annex 11
  • Predicate rules and Part 11/Annex 11 requirements overview
  • Part 11/Annex 11 related SOPs
  • Similarities and differences between Part 11 and Annex 11
  • Inspection trends with examples of some recent 483s and WL
  • What are auditors trained to look for during a Part 11/Annex 11 "tag along" audit
Who should Attend
  • Regulatory, QA/QC Department
  • Healthcare Industry
  • IT and Software Quality Assurance
  • Engineering, Manufacturing and Manufacturing Science
  • Project management and Validation

Past Events

Important

Please, check "CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Healthcare

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