Webinar Series on Data Integrity: Audit Trail Review from an Inspector's Point of View - Webinar Recording

Webinar Series on Data Integrity: Audit Trail Review from an Inspector's Point of View - Webinar Recording

Costs

ECA-Member*: EUR 199,--
Regular Fee*: EUR 249,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

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

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 Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

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
Recording from 17 July 2020
Duration of the recording: about 1.5 h

 

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