The current GMP Detox YouTube clip by Markus Roemer discusses the significant potential of AI technologies in the pharmaceutical industry. However, it highlights the current lack of the understanding and implementation of regulatory guidelines and regulations for the validated and compliant use of AI in regulated environments. The current GMP Detox session on YouTube emphasizes the approach and concept of AI validation and suggests strategies for ensuring safe AI deployment and validation for GMP / GXP operations.
👩💻 AI / ML / DL – it’s a true revolution – is it?
👩💻 EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 – (Artificial Intelligence Act)
👩💻 Classification rules for high-risk AI systems
👩💻 Legal act of Union harmonisation legislation
👩💻 The AI Act Explorer and supplier AI competence
👩💻 EU AI Act Compliance Checker
👩💻 EU-US TTC Joint Roadmap for Trustworthy AI and Risk Management
👩💻 AI Watch and CoPilot Knowledge Example
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https://www.youtube.com/watch?v=WI5SV4U1FLQ&t=193s