הנושאים שמעניינים אותי
(אפשר לבחור מספר נושאים)
מערכות ממוחשבות ובינה מלאכותית (AI)Annex 11 המשופר ו Annex 22 החדש
סדנה אינטראקטיבית
The EU GMP are under major revision. The digital revolution, Artificial Intelligence and Machine Learning are here including in the pharmaceutical industry. Come and hear how regulators are addressing these hot topics and what the proposed regulations require.
- Annex 11, Computerised Systems
- Annex 22 (new), Artificial Intelligence
In addition,...המשך קריאה
יש לך שאלה? יש לנו את כל התשובות
מה תכני הקורס?
- Computerised System Definition
- System Design
- Design Qualification with risk management
- Proactive vs Reactive:
Use of Risk-Based thinking - Governance: Documentation vs Data
- Governance: Computerised Systems
- Governance: Artificial Intelligence
- AI: intended use
- Review of the GMP drafts: Computerised Systems, Artificial Intelligence
- How to get ready: which elements are here to stay
- Gap analysis
למי זה מתאים?
This course is suitable for:
Anyone working in the pharmaceutical industry including Company General Managers, Managing Directors, QPs, Quality Assurance, Quality Control and other quality professionals, Operations Managers, Production Managers, Research and Development, persons working in technology transfer, personnel working in pharmaceutical Active Substance and finished product manufacture. Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course useful.
מה אקבל מכך בפועל?
At the end of this course:
- participants are updated on regulatory expectations for documentation, data, computerised systems, and controlled introduction AI/ ML use in their companies.
- Participants are equipped with tools to arrange a gap analysis, some to conduct one.
מי מעביר את הקורס?
