(AI) Artificial Intelligence in a GxP Environment - Live Online Training
9/10 October 2023
Seminar-Nr. 21232
Zielsetzung
Why should you participate in this event?
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 Live 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
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary Installation is fast and easy.
Pre-Training Course on IT Basics for AI - 9 October 2023
Introduction to Artificial Intelligence (AI) Stefan Münch / Yves Samson
History of AI
Types of AI
Real life examples
Introduction to Machine Learning (ML) 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
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
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
US / FDA: Expectations and guidance
EU / EMA: Expectations and guidance
Special case: Generative AI
(AI) Artificial Intelligence in a GxP Environment - 10 October 2023
Regulatory Requirements / Concerns Dr Arno Terhechte
Pharmaceutical laws (AMG and other)
EU-GMP Guide Annex 11
Concept Paper Revision of Annex 11
Software as Medical Device
Validation Approaches Stefan Münch / Yves Samson
Maturity: Increasing autonomy and transferring Control
Governance: Developing and operating AI solutions in GxP-regulated areas
Risk Management Stefan Münch / Yves Samson
Power with control: Explaining the outcomes of trained models
Applying QRM to development and operation of AI applications
Regulatory Requirements / Assessment Dr Arno Terhechte
Inspection strategy
What do inspectors expect from the regulated user?
Case Study: Predictive Control of Yield & Titer Dr Hadj Latreche
Apply Advanced Analytics to enable predictive Titer/Yield and reduce variability while increasing mean toward high-end value
In-Flight predictive and adaptive process oversight for shop floor to target Titer/Yield Golden Batches
Prove the value of utilizing Advanced Analytics as a digital product leveraging different data sources and advanced predictive algorithms
Build site future capabilities required for a sustainable way of working using Advanced Analytics
Case Study: AI in Medical Device Area Christophe Girardey
Introduction on the regulations in Medical Device area
AI in Medical Device:
Patient risk: more direct than in Pharma?
Reality not future: FDA list of devices released.
Guidelines on AI:
(FDA GMLP > optional as already covered in one of the other sessions)
AI & Cybersecurity (ENISA guideline)
NMPA Guideline on AI
Examples of a use case:
Electrocardiogram analysis with AI
Case Study: Revolutionizing Visual Inspection with Artificial Intelligence Dr Mario Holl
Pain points in visual inspection
A machine-agnostic AI solution Framework
Strategies for developing robust and reliable AI models
Qualification and necessary documentation
Results of AI powered visual inspection
Case Study: Challenges and Limitations of Machine Learning Systems in Automated Visual Inspection Systems Haluk Dönmez
Introduction and Basics
Application and Challenges
Approach and ML Training
Testing and Qualification
Conclusion
Enhancing Production Efficiency: An End-to-End Process Perspective through Data Science Julius Kittler / Thomas Singer
Introduction and Overview of the Use Case
Consolidating the Tablet Production Process into a Comprehensive Dataset
Theoretical Basics of Machine Learning and Gradient Boosting Decision Trees
Application of Machine Learning to Identify Critical Factors Impacting Production Target Variables
Key Takeaways and Lessons Learned
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Teilnehmerstimmen - das sagen andere über unsere Seminare:
"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen. Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.” Christian Wagener, WAGENER & CO. GmbH GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024
„Austausch zwischen Teilnehmern & Vortragenden sorgt für Anstöße & Optimierungsmöglichkeiten im eigenen Unternehmen! Praxisnahe Beispiele veranschaulichen und vertiefen die Theorie sehr gut“ Marina Maier, CHEPLAPHARM Arzneimittel GmbH
Abweichungen und CAPA (QS 12) November 2024
„Danke für das tolle und interessante Seminar! Ich nehme mir fachlich total viel mit und habe viele tolle Menschen kennengelernt.“ Melanie Schifferer, DAIICHI SANKYO EUROPE GmbH Batch Record Review (QS 23) September 2024
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023
„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“ Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024
Teilnehmerstimmen
Seminarprogramm als PDF
Sonderkonditionen DB Bahn