מערכת HVAC במפעלים פרמצבטיים וביוטכנולוגיים

Early Registration Discount
Early registration until November 16, 2018
3,170 NIS + VAT
Registration from November 17, 2018
3,700 NIS + VAT

Date: 26, 27 November 2018
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 2 - Day Course
Hours: 9.00 - 17.00
Price: 3,700 NIS + VAT
Credit Points: 2
SKU: 18658
Course Language: Hebrew
About the Course
TBA
Who should attend
TBA
מערכת HVAC במפעלים פרמצבטיים וביוטכנולוגיים
Benefits to the Participants
TBA
Contact us
  • Full Name
  • Email
  • Phone
  • Notes
  • Send
Issues to be covered
Day 1
  • Introduction to HVAC systems
    • History of HVAC
    • Major Uses
    • The science behind HVAC systems
    • Working principles of HVAC
  • Design of Air Handling Units
    • HVAC design challenges
    • The Psychrometric table and charts
    • Main components of an HVAC System
    • Heat Exchangers, Fans and Duct Systems
    • Configuration of Air handling systems
    • Equipment Selection
    • Examples
  • Air Filtration for Quality Control
    • Methods of air distribution and extraction
    • Types of filters
    • Filtration processes
    • HEPA Testing and certification
  • Facility Design for Particle Control
  • Facility layout and typical controlled area specifications including OSD and Laboratories
  • Design features for dust  and contamination control and prevention of cross-contamination
  • Differential Pressure  and  Airflow regimes
  • Use of barrier systems and unidirectional airflow devices  (PLF)
  • Exercise

Day 2

  • Qualification of HVAC Systems and Room Environments
    • Risk-based approach
    • Impact and Quality Risk Assessments
    • Design Qualification
    • P&ID Symbols and How to read it for an HVAC systems
    • IQ/OQ/PQ
    • Documentation examples
    • How should a protocol look like
  • Maintaining the Validated State
    • Change Management
    • Ongoing Quality Risk Management
    • Continuous Improvement
    • Non-Conformance Management
  • Particle Monitoring
    • How optical particle counters work
    • Particle counting technology (including airborne rapid micro sampler and how they work)
    • Classification vs. monitoring of clean zones
    • Classification worked examples
    • FDA CGMP & EU GMP Annex 1
    • Monitoring systems
    • Understanding particle monitoring data
  • Microbial Monitoring
    • What has to be monitored and when?
    • Routine and periodic monitoring requirements
    • Differences between Aseptic and Non-Sterile Areas
    • What equipment is needed?
    • Where should we monitor?
    • What standards should be applied?
    • Location and frequency examples
    • Effective data management and reacting to data
  • Summary
About The Lecturer

Mr. Jose (Yossi) Chvaicer

Senior Project Manager, Validation of Equipment and Utilities.
Mr. Chvaicer has over 20 years of international professional experience in the Pharmaceutical Industry. He is an expert in Validation of Equipment and Utilities (DQ/IQ/OQ/PQ) and has a broad background in managing large magnitude engineering projects, including design and building production sites, granulation and packaging lines, analytical laboratories and warehouses.
For more information please click here


Dr. Sigalit Arieli-Portnoy


For more information please click here


Learning from us