Roland Miksche
MiRo Consulting
Referierende
Zielgruppe
This 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.
Zielsetzung
This Online Training Course 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.
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
Weitere Informationen
To participate in a recording, 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 recording, you can decide on what date you want to watch the training course online. Starting from the access date you entered during the registration process, the stream will be available to you for 7 days. Within this timeframe, you can start and 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.
Timing and Duration:
When you register for the recording, you can decide on what date you want to watch the training course online. Starting from the access date you entered during the registration process, the stream will be available to you for 7 days. Within this timeframe, you can start and 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.
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.
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.
Conference language
The official conference language is English.
The official conference language is English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 6221 84 44-13, schopka@concept-heidelberg.de
Recording from September 2026
Duration of the recording: 2h 50m
Teilnahmegebühr
| ECA-Member*: | € 690,- |
| Regular Fee*: | € 790,- |
| EU/GMP Inspectorates*: | € 690,- |
| APIC Member Discount*: | € 740,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
