Stefan Münch, Körber Pharma Consulting, Germany
Yves Samson, Kereon, Switzerland
- 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
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.
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.
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 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.
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
- IT vs OT
- Specificities and features of IT systems
- Controllers and process control systems
- Bare metal
- Process data
- Initial / raw data
- Data integrity: ALCOA+
- The importance of data
- 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
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
- GAMP® software categories
- Risk Management
Computerised System Validation 2
- Use cases / User stories
- Creating URS interactively
- Testing Automated testing
Applying Critical Thinking
- What critical thinking really means
- Paradigm shift or false promise?
- When and why to apply critical thinking
Introduction to Cloud Computing
- Deployment models
- Service models
- Areas of concern
Introduction to Artificial Intelligence
- Machine learning
- Data for AS & ML
- Deep learning
- 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
- CSA (Computer Software Assurance)
- Data privacy & GDPR
- Intellectual property
Recording from 8/9 June 2022
Duration of the recording: approx. 13 h 10 min