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Wednesday, 16 September 2026 9 .30 - 14.30 h
Speakers
Objectives
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.
Background
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 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 cannot be accidentally overwritten, templates cannot be changed or deleted, and that traceability of input, processing and output is trustworthy. Furthermore, accidental input of inappropriate data types should be prevented. However, controls are quite often inadequate and this may result in compliance risks. Such Excel applications may easily come into focus during authority inspections.
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 cannot be accidentally overwritten, templates cannot be changed or deleted, and that traceability of input, processing and output is trustworthy. Furthermore, accidental input of inappropriate data types should be prevented. However, controls are quite often inadequate and this may result in compliance risks. Such Excel applications may easily come into focus during authority inspections.
Background
Wed, 16 September 2026, 09.30 - 14:30 h
All times mentioned are CEST.
Target Group
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:
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
It is also aimed at 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.
Programme
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
Questions and Answers Sessions
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT)
ECA Members EUR 690.-
APIC Members EUR 740.-
Non-ECA Members EUR 790.-
EU GMP Inspectorates EUR 690.-
The fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 (0)6221 84 44 13, schopka@concept-heidelberg.de
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT)
ECA Members EUR 690.-
APIC Members EUR 740.-
Non-ECA Members EUR 790.-
EU GMP Inspectorates EUR 690.-
The fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 (0)6221 84 44 13, schopka@concept-heidelberg.de