Hands-on Aseptic Processing Course
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
Wednesday-Thursday
08:30-17:30
Scinai Immunotherapeutics
Jerusalem BioPark Building
Hadassah Ein Kerem Campus
Jerusalem, Israel
Early bird registration till 1-5-24
6300 NIS + vat
Full Price
7000 NIS + vat
Glance into the Syllabus:
Delving into Fill and Finish design principles, aseptic processing with hands-on facility tours
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09:00 - 10:00
Biological production facility Inc. Fill and Finish design, facility layout flows principles
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10:00 - 11:00
Aseptic processing principles- introdution (Different grades & related activities, FDA vs Annex 1, different filling options, barrier technologies)
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11:00 - 11:15
Coffee break
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11:15 - 12:45
Tour including different grades, filling area, LAF and BSC, SU bags vs stainless steel demonstration of aseptic connections
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12:45 - 13:15
Lunch
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13:15 - 14:30
Working principles in grade A, filtration, Clean room behaviour- gowning, materials , equipment, material/ people/ waste flow
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14:30 - 15:15
Tour in warehouse, metarial entrance, people and waste flow, demonstrate proper gowning for grade C & B
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15:15 - 15:30
Coffee break
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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
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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
Exploring contamination control strategies, environmental monitoring, and aseptic process simulations
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09:00 - 10:45
Contamination control strategy and risk assessment, including case studies
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10:45 - 11:00
Coffee break
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11:00 - 12:00
EM and trend analysis
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12:00 - 12:45
Sampling equipment and employee's sampling demonstration - practical demonstration
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12:45 - 13:15
Lunch
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13:15 - 14:15
Aseptic process simluation: regulatory requirements
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14:15 - 15:15
Video of aseptic behaviour. Optional - BSC demonstration
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15:15 - 15:30
Coffee break
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15:30 - 16:30
Q&A
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16:30 - 17:30
Summary
* 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
Lecturers
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, MOHDon't miss this unique opportunity to advance your skills and knowledge in aseptic processing
*Limited number of participants.
For more information, please contact:
nitsan@adres.bio | 052-8034927
