21 CFR Part 11 - Complete Manual for Compliance and Success 2012

  • 13 Nov 2012
  • Webinar

Description

Topics
  • Internal and External Auditing for Part 11 Compliance
  • How to prepare and host FDA inspection when Part 11 is in scope
  • Overview and Correlation of Part 11 with other regulations
  • Audit Trails: Ins and Outs
  • Sample Audit Questions
  • Trends, Warning Letters, Advantages and Disadvantages of Compliance/Use of Part 11
Who should Attend

Regulatory Affairs, IT/ IS, Quality Engineers, Product development engineers, Internal and External Quality Auditors, Quality Managers, CAPA investigators, Management Representatives and Project managers.

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Important

Please, check "21 CFR Part 11 - Complete Manual for Compliance and Success" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Pharma
Technology: Information Technology (IT)

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