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Excel in the GxP-regulated Environment - Online Training Recording

Seminar-Nr. 21770

Referent:innen

Roland Miksche

Roland Miksche

MiRo Consulting

Zielsetzung

This Live Online Training aims to give participants a comprehensive overview of regulatory, technical and data integrity requirements for using Excel spreadsheets in a regulated GxP-environment. The translation of regulatory requirements into a lean and compliant approach will be demonstrated. Practical examples, exercises (including polling questions) and Q&A sessions ensure interaction and that all questions are answered.

Hintergrund

Excel is widely used in laboratories, in production as well as in quality departments in both larger and smaller companies for GxP-relevant applications. The easy to use of spreadsheets allow making calculations, selections and colourful presentations in a very convenient way.
Quite often, numerous risks with regard to data integrity result from the diverse, flexible and sometimes very complex application possibilities. If Excel is used in a GxP-regulated environment for quality-relevant tasks, regulatory and data integrity requirements must be met. Files and calculations should be secured in such a way that formulas are not accidentally overwritten, templates are not changed or deleted and traceability of input, processing and output is trustworthy. 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 course 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: ƒ
  • 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.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.

Programm

Regulatory and Data Integrity Requirements
  • Overview of regulatory and data Integrity requirements
  • ALCOA+
  • Industry standard (GAMP 5)
  • Findings for spreadsheets
Application of Requirements (including Exercises)
  • Lifecycle approach according to GAMP 5
  • Intended use (user requirements)
  • Inventory
  • Classification (criticality and complexity)
  • Areas of usage (e.g. quality control, manufacturing)
  • Developer qualification
  • Design (operations, data flows, functional and design specification)
  • Installation and qualification (build, test plan and report)
  • Formal release
  • Procedure for use and operation (SOP)
  • Procedure for system Administration
  • Decommissioning
  • Practical examples
Technical Solutions
  • Central services (terminal server, data server)
  • Protection, access Management
  • Data validation, user guidance
  • Name Manager
  • Coding Standards
  • Maintenance, changes (template cycle)
  • Backup, disaster recovery, Business continuity
  • IT support
Recording from 02.05.2024
Duration of the recording: approx. 3 h

 

ECA-Member*: € 590,-
Regular Fee*: € 690,-
EU/GMP Inspectorates*: € 590,-
APIC Member Discount*: € 640,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

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Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

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