Topic Speaker

Opening Remarks

Karin Baer
09:15-10:00 Overview of the new Annex 1draft – Regulatory point of view
Rachel Shimonovitz
Head of GMP inspectorate
Ministry of Health
10:00-10:45 Overview of the new Annex 1 draft – Industry point of view Galit Afik
QA Director, R&D and Technology Transfer, Kamada
10:45-11:15 Coffee Break
11:15-12:00 Viable and non-viable environment: qualification & process monitoring Noga Katar
QA & Validation
Ludan Engineering Ltd
12:00-12:45 The future in sterile technologies Tali Bennun
Sr. Quality Director
Teva Pharmaceuticals
12:45-13:45 Lunch
13:45-14:30 Aseptic Process Simulation (Media Fill) Chemi Shwartz
Clean Rooms Manager SciVac Ltd Israel
14:30-15:15 Clean utilities, Clean rooms and HVAC - ISPE comments to new annex 1 Sarel Chen-Tov
CEO, Biopharmax Ltd
15:15-15:45 Coffee Break
15:45-16:30 A risk based approach for the Annex 1 draft Karen Ginsbury
PCI Consulting Israel
16:30-17:00 Wrap up


QA, RA, Engineering and Production, Validation

Participation Fees:
PDA members - 650 NIS
Non members - 850 NIS 


Organized & Produced by
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Fax: 08-9313071
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