IT for Non-IT Professionals - Online Training Recording

IT for Non-IT Professionals - Online Training Recording

Costs

ECA-Member*: EUR 1690,--
Regular Fee*: EUR 1890,--
EU/GMP Inspectorates*: EUR 945,--
APIC Member Discount*: EUR 1790,--

(All prices excl. VAT). Important notes on sales tax.

Registration
* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Stefan Münch, Körber Pharma Consulting, Germany
Yves Samson, Kereon, Switzerland

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
  • ƒCompany 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 ƒ 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

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