IT for Non-IT Professionals - Online Training Recording
Course No. 21685
Speakers
Yves Samson
Kereon
Stefan Münch
Körber Pharma Consulting
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.
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.
Technical Details
Um an einem On-Demand-Training oder Webinar teilzunehmen, benötigen Sie keine Software. Die Aufzeichnungen werden über einen Streaming-Server zur Verfügung gestellt. In der Regel wird die Aufzeichnung im MP4-Format bereitgestellt, das jeder PC (Microsoft Windows, Apple IOS) oder jedes Tablet problemlos darstellen kann.
Zeitplan und Dauer: Wenn Sie sich für ein On-Demand-Seminar oder -Webinar registrieren, können Sie entscheiden, zu welchem Zeitpunkt Sie sich das Seminar online anschauen möchten. Bei einer 1-Tages-Schulung haben Sie 2 Tage, in denen der Stream zur Verfügung steht (bei einer 2-Tages-Schulung 3 Tage und bei einer 3-Tages-Schulung 4 Tage). Innerhalb dieses Zeitraums können Sie den Stream je nach Bedarf starten und stoppen.
Rechtzeitig vor dem geplanten Termin (Ihrem Wunschtermin) erhalten Sie von uns eine E-Mail mit einem Link zur direkten Teilnahme sowie Ihre Log-in-Daten.
Bitte beachten Sie: Aufgrund des Datenschutzes liegen die Fragen und Antworten-Runden nicht als Aufzeichnung vor.
Präsentationen und Zertifikat:
Die Präsentationen werden Ihnen kurz vor dem Online Seminar als PDF-Datei zur Verfügung gestellt. Alle Teilnehmer/innen erhalten im Anschluss an das Seminar ein Teilnahmezertifikat zugesandt.
Programme
CSV Regulatory Background
What is a computerised system
What the heck do qualification and validation actually mean
Applicable regulatory framework
Typical weaknesses
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
Testing Automated testing
Traceability
GAMP 5 2nd edition
Critical thinking
Risk based approach
CSA (Computer Software Assurance)
Introduction to Cloud Computing
Deployment models
Service models
Areas of concern
Leveraging Supplier Involvement
What leveraging really means
Common pitfalls (and how to avoid them)
How to reduce duplicate efforts
Supplier audits
IT Trends and Challenges
Recording from 27./28. February 2024 Duration of the recording: 13h 30min
Testimonials