Webinar Series on Data Integrity: Audit Trail Review from an inspector's point of view

Webinar Series on Data Integrity: Audit Trail Review from an inspector's point of view

Course No 18188

Important: Deadline is 12 noon on 16 July 2020

You will find all webinars of this series in this overview

Costs

ECA-Member: EUR 199,--
Non ECA Member: EUR 249,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Franz Schönfeld, District Government of Upper Franconia

Background

Audit Trails and their reviews are an important requirement in the current GMPs. Since 2011, the EU GMP Guideline Annex 11 “Computerised Systems” is demanding records of all GMP relevant changes and deletions to be implemented as a system-integrated Audit Trail: the reasons for changes and deletions must be documented. Audit Trails must be available, convertible into a generally readable form and also must be checked regularly. Despite the various guidelines which were published after 2015 the discussion about the requirements for Audit Trail reviews and how they can be implemented in the daily business is still on-going.

Target Group

The Webinar is focussing on the critical elements of Data Integrity and Audit Trail Review:
  • Quality assuranceƒ
  • Production
  • ƒQuality Control
  • IT Department
  • Inspections and audits

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

The Webinar is focussing on the critical elements of Data Integrity and Audit Trail Review:
  • Principles of Data Integrityƒ
  • Data Ownersƒƒ
  • Levels of Audit Trail Reviews
  • Investigation and CAPAs
  • Examples of Audit Trail Reviews
  • Findings

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