Stefan Münch
Körber Pharma Consulting
Referent:innen
Nicolas Schaltenbrand
Wega Informatik
Christophe Girardey
wega Informatik
Yves Samson
Kereon
Zielsetzung
Why should you participate in this online training?
- You will learn the basics of AI / ML and its applicability in the GxP Environment
- How can pharmaceutical basics, e.g. risk management and qualification / validation be applied to AI? You will experience first approaches!
- Are relevant pharmaceutical regulations adapted to this new technology and what expectations does an inspector have during an inspection? First concepts will be presented!
- In case studies, pharmaceutical companies show first practical and practised approaches to the use of AI
Hintergrund
At the latest, artificial intelligence (AI) has arrived in the General public since ChatGPT and Bard. Opinions range between absolute euphoria and the invocation of the downfall of humanity. The foundations of AI were laid many years ago and can now be widely implemented due to massively available computing power. The topic has also found its way into the pharmaceutical landscape. First applications have come into operation. The interesting questions here are whether and how this technology is compatible with pharmaceutical regulations, specifications and authorities’ expectations.
Zielgruppe
The Online Training is aimed at managers and QA members as well as engineers from the pharmaceutical industry, suppliers and service companies who qualify and operate AI applications in a GxP environment.
Technical Requirements
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:
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.
Training Course Documentation and Certificate:
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programm
Introduction to Artificial Intelligence (AI)
Stefan Münch / Yves Samson
Stefan Münch / Yves Samson
- History of AI
- Types of AI
- Real life examples
Introduction to Machine Learning (ML)
Stefan Münch / Yves Samson
Stefan Münch / Yves Samson
- Technological Basics
- Different learning / training Methods
- Example use cases
AI/ML in Pharma, Biotech and Med Devices
Stefan Münch / Yves Samson
Stefan Münch / Yves Samson
- Challenges for pharmaceutical Industry
- The GAMP-perspective on AI/ML
- GMLP: SDLC for AI/ML
- Use cases / Known scenarios
Data Science as Basis for AI
Nicolas Schaltenbrand & Christophe Girardey
Nicolas Schaltenbrand & Christophe Girardey
- Pre-requisites for AI: Data Governance, Data Science, Data Understanding, FAIRification.
- Specificities in the lab
- Lack of standardization, Lack of connectivity.
- Chances with standards: AniML, SiLA
- Specificities in clinical development
The Regulatory Landscape for AI/ML
Stefan Münch / Yves Samson
Stefan Münch / Yves Samson
- US / FDA: Expectations and guidance
- EU / EMA: Expectations and guidance
- Special case: Generative AI
Recording from 9 October 2023
Duration of Recording: approx. 3:43 h
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 345,- |
| APIC Member Discount*: | € 640,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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