Annex 11 & Part 11 Computerized Systems, Electronic Records and Electronic Signatures — Scope and Application

Conducted by: Mr. Mike Zeevi
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The European Commission (CE) issued the GMP with Annex 11: Computerized Systems. The FDA issued the Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application. These guidances try to give directions in relating to computerized systems/electronic records and electronic signatures. There are differences in the two guidances in their scope and their requirements.

The European Commission (CE) issued the GMP with Annex 11: Computerized Systems. The FDA issued the Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application. These guidances try to give directions in relating to computerized systems/electronic records and electronic signatures.
There are differences in the two guidances in their scope and their requirements.

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Dates: 
  • 15/03/2021
  • 17/03/2021

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    Course location: Zoom Course
    Duration: 2 half-day Course (Morning)
    Hours: 09:00 - 12:30
    Credits: 1
    Course Language: עברית

    Course price: ₪1,700 + VAT
    Early registration is Closed
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    Issues to be covered

    This seminar describes the following:

    • Understanding the basic terminology of Annex 11 and 21 CFR Part 11
    • Determining which systems in your organization that need to comply with this ruling
    • Understanding the difference between 21 CFR Part 11 and Annex 11
    • Understanding HIPAA as compared to Annex 11 and Part 11
    • Looking into document control systems
    • Understanding what are electronic submissions
    • Knowing what your options are and where you should be going

    About The Lecturer

    Mike Zeevi
    Mike Zeevi is a senior consultant for software validation and software
    Read more
    תחזוקת מערכת האיכות בזמן מלחמה QMS

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