Roland Miksche, MiRo Consulting, Vienna, Austria
MS Excel is widely used in laboratories as well as in production. Excel spreadsheets are used in both larger and smaller companies for GxP-relevant applications. However, numerous risks with regard to data security result from the diverse and flexible application possibilities. If Excel is used in a GxP-regulated environment for quality-relevant tasks, special requirements must be met. Such Excel applications may easily come into focus in authority inspections.
But what exactly is necessary to use this powerful tool GxP-compliant and how to pass an Audit?
This webinar is aimed at all those responsible for Excel applications in the various departments (e.g. quality control, quality management, production, IT). These are, e.g. coworkers and high-level personnel from the following industries:
- Pharmaceutical companies
- API manufacturer
- GLP Laboratories
- other companies working according to GxP
Also addressed are employees of medical device manufacturers as well as of universities and research institutions who, for regulatory reasons, have to use Excel in a GxP-compliant way.
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.
The following topics are addressed:
- Areas of usage in the GxP environment
- Authority requirements and findings
- Spreadsheet categorization according to GAMP 5
- Life cycle model (from requirement to decommissioning)
- Presentation in the context of an audit
- Best practices from the pharmaceutical industry
Recording from 12.05.2020
Duration of the recording: approx. 1,5 h.