Roland Miksche, MiRo Consulting, Vienna, Austria
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.
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.
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.
For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://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.
Regulatory Requirements and Areas of Usage
- Regulatory Requirements
- Areas of usage in the GxP environment (e.g. Quality Control, Manufacturing)
Technical Requirements and Security
- Technical solutions
- Developer Qualification
- Protection, Access
- Maintenance, Changes
- Lifecycle: Intended use – Decommissioning
- IT support
Questions and Answers Sessions
- Participants are invited to ask questions.
- Practical examples
- Poll questionnaires