For the first time in Israel

Hands-on Aseptic Processing Course

26-27 June 2024
08:30-17:30 | Jerusalem

Your gateway to mastering aseptic operations: An exclusive course for pharmaceutical and biotech professionals.

A comprehensive course for mastering the critical aspects of aseptic operations, with theory and practical sessions led by pharma industry experts in Scinai’s state-of-the-art facility. This course is led by Scinai and ADRES and includes lectures by Ministry of Health officials.

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*Limited number of participants!

    Course Highlights:

    • Interactive tours of Grade A, B, and C manufacturing facilities
    • Lectures by Mrs. Rachel Shimonovitz, Head of GMP Inspectorate, MOH
    • Roundtable and Q&A - With Dr. Ofra Axelrod, Head of ISCP, MOH
    • Insightful case studies
    • Practical and hands-on demonstrations of aseptic techniques and gowning procedures
    • Regulatory insights

    26-27 June 2024

    Scinai Immunotherapeutics
    Jerusalem BioPark Building
    Hadassah Ein Kerem Campus
    Jerusalem, Israel

    Early bird registration till 31-5-24 
    6300 NIS + vat
    Full Price 
    7000 NIS + vat

    Glance into the Syllabus:

    Day 1

    Delving into Fill and Finish design principles, aseptic processing with hands-on facility tours

    1. 09:00 - 10:00

      Biological production facility Inc. Fill and Finish design, facility layout flows principles

    2. 10:00 - 11:00

      Aseptic processing principles- introdution (Different grades & related activities, FDA vs Annex 1, different filling options, barrier technologies)

    3. 11:00 - 11:15

      Coffee break

    4. 11:15 - 12:45

      Tour including different grades, filling area, LAF and BSC, SU bags vs stainless steel demonstration of aseptic connections

    5. 12:45 - 13:15


    6. 13:15 - 14:30

      Working principles in grade A, filtration, Clean room behaviour- gowning, materials , equipment, material/ people/ waste flow

    7. 14:30 - 15:15

      Tour in warehouse, metarial entrance, people and waste flow, demonstrate proper gowning for grade C & B

    8. 15:15 - 15:30

      Coffee break

    9. 15:30 - 16:30

      Regulatory Authorities observations facilities’ inspections – lessons learned and how they relate to Annex 1- By Mrs. Rachel Shimonovitz, Head of GMP Inspectorate, MOH

    10. 16:30 - 17:00

      Roundtable and Q&A - With ADRES and Scinai experts and With Dr. Ofra Axelrod, Head of ISCP, MOH and Mrs. Rachel Shimonovitz, Head of GMP Inspectorate, MOH

    Day 2

    Exploring contamination control strategies, environmental monitoring, and aseptic process simulations

    1. 09:00 - 10:45

      Contamination control strategy and risk assessment, including case studies

    2. 10:45 - 11:00

      Coffee break

    3. 11:00 - 12:00

      EM and trend analysis

    4. 12:00 - 12:45

      Sampling equipment and employee's sampling demonstration - practical demonstration

    5. 12:45 - 13:15


    6. 13:15 - 14:15

      Aseptic process simluation: regulatory requirements

    7. 14:15 - 15:15

      Video of aseptic behaviour. Optional - BSC demonstration

    8. 15:15 - 15:30

      Coffee break

    9. 15:30 - 16:30


    10. 16:30 - 17:30


    View the full Syllabus

    * Please note that this syllabus is not final and is subject to change. Scinai & ADRES reserve the right to make adjustments to the schedule, assignments, and other course components as necessary. Students will be notified of any significant changes in a timely manner


    Elad Mark

    Chief Operating Officer at Scinai Pharmaceuticals Ltd.

    Rivka Zaibel

    Founder and President of ADRES int'l biotech consulting & Execution

    Tehila Sonnenfeld Ph.D

    Director of Production at Scinai Pharmaceuticals Ltd.

    Tamar Oved Ph.D

    QA & CMC Director at ADRES

    Mrs. Rachel Shimonovitz

    Head of GMP Inspectorate, MOH

    Don't miss this unique opportunity to advance your skills and knowledge in aseptic processing

    *Limited number of participants.

    For more information, please contact: | 052-8034927

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