IT for Non-IT Professionals Understand your IT

IT for Non-IT Professionals

Heidelberg, Germany

Seminar Nr. 20595

This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager". Learn more.

 

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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

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

Zielsetzung

  • 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

Hintergrund

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.

Zielgruppe

The Training Course 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.

Programm

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
  • 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

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