Audits / Inspections of Computerised Systems - Gaining Practical Insights - Recording Webinar

Audits / Inspections of Computerised Systems - Gaining Practical Insights - Recording Webinar

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 Timo Kretzschmar, anapur AG Region Wien, Austria

Background

Computerised systems have continuously developed over the years as an “omnipresent companion” in the GxP landscape. It is not a “clearly representable” area, but an inherent dimension in the entire GxP with a rapidly growing influence on drug safety.

As practical difficulties in the classification and treatment of computerised systems reveal, they are sometimes difficult to “separate” from their environment, can only be grasped in their entirety and thus be identified as GxP-relevant in the given case.

Computerised systems include a wide variety of forms of appearance, e.g.:
  • Excel spreadsheets (with formulas)ƒ
  • Production-supporting software without sensors / actuators via (individual) controls of production equipmentƒ
  • complex process control systemsƒ
  • broadly based cloud systems of global organisationsƒ
In order to use resources carefully, it is advisable to use audits to illuminate this jungle of possibilities with the „glasses of compliance“ before actions are taken.

The focus of this webinar is on the target-oriented use of audits to achieve compliance with legal and operational requirements. This works best accompanied by the practical, continuous improvement and development of the ability to distinguish the necessary from cosmetic issues. This prevents audits from becoming formal activities.

Target Group

The webinar is aimed at managers from all areas of quality, automation, IT and technology, who, as auditors or auditees, have to deal with computerised systems / data integrity with regard to the preparation, implementation and / or follow-up of internal / external audits and official inspections.

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 aim of the webinar is to make better accessible issues that arise in practice around audits, such as:
  • Computerised systems – a new aspect in the compliance landscape?ƒ
  • What are computerised systems from an auditor’s perspective?ƒ
  • Are computerised systems “formalised” auditable / inspectable?ƒ
  • What do audits / inspections reveal and what do they sharpen your eyes on?ƒ
  • How does understanding for the compliance of computerised systems arise?ƒ
  • Compliance, a necessary evil or a tool for controlling costs?ƒ
Recording from 22 July 2020
Duration of the recording: about 1.5 h

 

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