Roland Miksche
MiRo Consulting
Referent:innen
Zielsetzung
This Live Online Training aims to give participants a comprehensive yet compact overview of regulatory and technical requirements of using Excel in a GxP-regulated environment. Practical examples and exercises (including polling questions) and two Q&A sessions ensure interaction and that all questions are answered.
Hintergrund
Excel is widely used in laboratories as well as in production in both larger and smaller companies for GxP-relevant applications. The easy to use calculations allow making calculations in a very convenient way.
Quite often, 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. The files and the calculations should be secured in such a way that formulations are not accidentally overwritten. Furthermore, accidental input of an inappropriate data type should be prevented.
However, controls are quite often inadequate and this may result in a compliance risk. Such Excel applications may easily come into focus in authority inspections.
Quite often, 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. The files and the calculations should be secured in such a way that formulations are not accidentally overwritten. Furthermore, accidental input of an inappropriate data type should be prevented.
However, controls are quite often inadequate and this may result in a compliance risk. Such Excel applications may easily come into focus in authority inspections.
Zielgruppe
This Live Online Training is aimed at all those responsible for Excel applications in the various departments (e.g. Quality control, quality management, production, IT).
It will be of interest in particular for 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.
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:
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.
Programm
Regulatory Requirements and Areas of Usage
- Regulatory Requirements
- Findings
- Areas of usage in the GxP environment (e.g. Quality Control, Manufacturing)
Technical Requirements and Security
- Technical solutions
- Security
- Developer Qualification
- Protection, Access
- Maintenance, Changes
- Lifecycle: Intended use – Decommissioning - IT Support
Exercises
- Practical examples
- Poll questionnaires
Recording from 06.05.2021
Duration of the recording: approx. 3 h
Duration of the recording: approx. 3 h
| ECA-Member*: | € 490,- |
| Regular Fee*: | € 590,- |
| EU/GMP Inspectorates*: | € 490,- |
| APIC Member Discount*: | € 540,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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