Annex 11 & Part 11

 Computerized Systems, Electronic Records and Electronic Signatures — Scope and Application

Lecturer: Mr. Mike Zeevi

Date: 15 January 2019
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 1 - Day Course
Hours: 09:00 – 17:00
Price: 1,750 NIS + VAT
Credit Points: 1
SKU: 19052
Course Language: Hebrew
About the Course
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.
Who should attend
Annex 11 & Part 11
Benefits to the Participants
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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

Mr. Mike Zeevi

Mike Zeevi is a senior consultant for software validation and software quality assurance for the life science industry (medical devices, drug and bio-tech companies). Mike is also a leading authority on the CE’s and the FDA’s requirements for software validation including Annex 11 and 21 CFR Part 11.
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