IT for Non IT-Professionals - Online Training Recording
Understand the Relevance of your IT
Course No. 22639
Target Group
The online training is aimed at employees of pharmaceutical and medical companies, suppliers and service companies who deal with IT systems, but do not have a detailed understanding of their technical functions.
Objectives
You will gain a basic understanding of IT systems and how they work
You will learn how software is developed and tested
Data integrity is one of the basic requirements in the GMP world. What is the relevant data and how can its integrity be ensured?
You will be able to assess how the diverse and often very short-term technological developments in the IT sector are to be evaluated against the background of pharmaceutical requirements
Background
In today’s world, company operation is no longer possible without the use of IT. In the healthcare industry, as well, IT systems play an important role in all areas. In many cases, it is sufficient for the user to be able to operate the IT systems without knowing their basic functions.
In a highly regulated industry, the use of IT systems, especially with their ever-increasing networking, is also associated with risks and dangers. Currently, for example, the media extensively report about topics such as data and system security. The pharmaceutical industry has to face these topics in many respects.
Only those who know the characteristics and modes of operation of the systems and can assess their problems and dangers, are in a position to ensure the proper and safe operation of these systems.
Programme
CSV Regulatory Background
What is a computerised system?
Applicable regulatory Framework
What the heck does qualification and validation actually mean?
PIC/S
Technology: Hardware & Software Components
Company IT infrastructure
Network components
Switches, hubs and Firewalls
Server farm vs blade centre
Storage Systems - NAS & SAN
IT Landscape
IT vs OT
Specificities and features of IT Systems - Controllers and process control Systems - MES - ERP - LIMS - CDS - DMS
Technology - Bare metal - Virtualisation
About Data
Process data
Initial / raw data
Data integrity: ALCOA+
The importance of data
Data Management
Definitions - Terminology - Roles - Data LifeCycle - Data governance
Challenges of today‘s data Management
RAID Technology
Disaster Recovery & Business Continuity
Data Migration
Basics of Software Engineering
Reference model
V-model according to GAMP®
ASTM E2500-20
Spoon model
Operation
Alternative System Development Approaches
Alternative software development models
Agility objectives
Example: Scrum4LS as an agile SW development model
Icing on the cake: Continuous integration and test Automation
DevOps: How far can we go?
Computerised System Validation - 1 -
Basic principles
URS – User Requirements Specification
Responsibilities
GAMP® software categories
Risk Management
Computerised System Validation - 2 -
Use cases / User stories
Creating URS interactively
Testing
Automated testing
Traceability
GAMP 5 2nd Edition
Why a second Edition?
Documents vs records
Agility and tools
Critical Thinking and CSA (Computer Software Assurance)
Audit Trail (Review)
EU-GMP Annex 11 and Audit Trail
Which systems require an Audit Trail?
Audit Trail Review
GAMP 5 2nd Edition and Audit Trail
IT Trends and Challenges
Introduction to Cloud Computing
Cloud as part of IT Infrastructure
Cloud Service models
Opportunities and risks
AI – Artificial Intelligence
Basics of AI, ML, and DL
Life cycle of an AI-enabled System
Innovation vs regulation
Use cases
Cybersecurity
Threats
Security concepts
Leveraging Supplier Involvement
What leveraging really means
Common pitfalls (and how to avoid them)
How to reduce duplicate efforts?
Supplier Audits
Further Information
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 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.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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