קטגוריה: פרמצבטיקה/תרופות/מוצרים ביולוגיים , איכות , ואלידציה - תיקוף
Thermal Validation and Monitoring in GMP Environment

מרצה:
תאריך: 5, 6 יוני 2013
מיקום הקורס:  מלון דן פנורמה תל אביב
שפת הקורס: אנגלית
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
התכנסות והרשמה: 8:30-9:00
עלות: 2,150 ₪ לשני הימים
נקודות זכות: 1
מק''ט: 13629
Thermal Validation and Monitoring in GMP Environment
 
הקורס מועבר בשיתוף עם חברת אינסטרומטריקס בע"מ


 
In collaboration with



The GMP environment has undergone a big change over the past 20 years. Pharmaceutical companies need to comply with FDA and EU standards for thermal validation processes and for monitoring systems.
In this course participants will learn about how to fulfill these requirements.
The course will include an introduction on how to perform a temperature mapping and will explain the difference between a GMP monitoring system and a traditional Building Monitoring System (BMS).
Benefits to the Participants
  • Receive updates about the present norms & standards related to FDA and EU regulations.
  • How to achieve minimal total error budget
  • How to perform correct calibration
  • How to perform temperature mapping
  • Understanding monitor requirements
Issues to be covered
  Day 1 – Validation day
  • General overview of FDA EU regulations
  • Calibration theory
  • Wireless vs wired systems
  • Validation steam sterilizers
  • Validation ultra-low (cryo) applications
  • Workshop
Day 2 – Monitoring day
  • Introduction – regulations
  • Perform temperature mapping
  • GMP monitoring system vs Buidling Monitoring System
  • Hands-on exercise in wireless mapping
Who should attend
  • Validation managers
  • Validation engineers
  • QA managers
  • Calibration department leaders
  • Site managers
About the Speaker
Mr. Johan Stormlund
Year 2000, M.Sc. degree in Analytical chemistry in the University of Abo Akademi, Finland.
Worked as laboratory engineer at AstraZeneca, performing HPLC/GC studies and cleaning validation. Moved to AstraZeneca R&D department working mainly with LC/MS.
Year 2005 I joined the company Chromtech, as a Sales Manager. In charge of sales of Agilent Technologies Life Science portfolio.
Since 2008 part of GE Measurement & Control Validation & Monitoring as Account Manager and Sales Channel Manager. Covering Scandinavia, part of Eastern Europe and Israel.
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