Duration
|
Topic |
Speaker |
08:30-09:00
|
Registration |
| 09:00-09:15 |
Opening Remarks
|
Karin Baer
President |
| 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 |
