Computerized Systems – Annex 11 Revision, Data Integrity and the Quality SystemInteractive Workshop

Expert Lecturer: Mrs. Karen Taylor (Ginsbury)
Categories: Quality
SKU: 25808
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Annex 11 Computerized Systems is being updated. A 32 point, five page concept paper has been issued for comment. Of 32 points raised, NONE is addressed in the existing 5 page annex. Based on other GMP chapter / annex revisions, we can expect from 60 – 80 pages of detailed requirements for computerised systems in a GMP environment. There are...Continue reading

Annex 11 Computerized Systems is being updated. A 32 point, five page concept paper has been issued for comment. Of 32 points raised, NONE is addressed in the existing 5 page annex. Based on other GMP chapter / annex revisions, we can expect from 60 – 80 pages of detailed requirements for computerised systems in a GMP environment. There are many Data Integrity guides. 483 findings, warning letters appear at an alarming rate with the same findings over and over. The objective of this workshop is to understand what is really needed for the installation, qualification and lifecycle control of computerised system, including built-in Data Integrity safeguards.

In this course our Renowned specialist will present her experience and case studies to help understand how a effective management of computerised systems from design through lifecycle use, can overcome data integrity issues and cause a real improvement in the control of GxP critical data.

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Date:  27 October, 2025

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    Course location: Hybrid: Virtual & Scientific Park Nes Tziona Kiryat Weizmann
    Duration: 1-Day Course
    Hours: 09:00 - 17:00
    Credits: 1
    Course Language: Hebrew
    Course price: 2,550 NIS + VAT
    Early registration discount until October 19, 2025:
    2290 NIS + VAT.
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