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This seminar we will review regulatory
requirements for a new facility as well
as looking at the life cycle of a project
from conceptual design (URS -User Requirement
Specifications) to PO (Purchase Orders),
FRS (Functional Requirement Specifications),
FAT (Factory Acceptance Tests) and finally
SAT (Site Acceptance Tests). Specific
quality requirements will be discussed
and the case study of BTG will round off
the discussions. |
| Who
should attend? |
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This seminar
is intended for industry professionals
who are responsible for Engineering or
Engineering firms that are involved in
building or renovating pharmaceutical
and Biotech facilities, Quality Assurance,
Regulatory and validation personnel. In
addition, contractors, equipment and facility
suppliers and others who participate in
this process, such as process development
and operations personnel at all levels
of management will benefit from learning
what to expect and how to foresee and
prevent problems. |
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08.30
- 09.00
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Registration
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09.00 - 09.15
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Opening
Remarks |
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09.15
- 12.15
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Facility
Design from a PIC/s inspection view point
(including PIC/s as a jump-off for Israeli
mutual recognition)
Impact/Interaction of Facility Design
on GMP controls of therapeutic goods.
|
Mr.
Robert Tribe* |
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12.15
- 12.45
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Questions & Answers |
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12.45
- 13.45
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Lunch
& Vendor Exhibitions |
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13.45
- 14.20
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Conceptual
design in the Pharma/Biotech industry |
Mr.
Uri Doron |
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14.20
- 15.00
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Quality
aspects of a pharmaceutical project |
Dr.
Sigalit Portnoy |
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15.00-
15.30
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Coffee
Break & Vendor Exhibitions |
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15.30
- 16.15
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Case
Study - Lessons from building a biopharmaceutical
plant |
Mr.
Zvi Ben-Hetz |
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| *Key-note
speaker: Mr. Robert Tribe, Australia |
| Mr.
Tribe is a senior GMP Advisor at the Australian
Health Authorities and is a key member
of PIC/S. |
Registration
Fees:
Members -
900 NIS
Non-Members - 1095 NIS (includes membership
through 2004)
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