Excel in the GxP-regulated Environment - Online Training Recording
Course No. 21770
Speakers
Roland Miksche
MiRo Consulting
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 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.
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:
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.
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
Recording from 02.05.2024 Duration of the recording: approx. 3 h
Testimonials