Forum Bio-Log: www.forumsci.co.il




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?
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.

08.30 - 09.00
Registration
09.00 - 09.15
Opening Remarks
09.15 - 12.15
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*
12.15 - 12.45
Questions & Answers
12.45 - 13.45
Lunch & Vendor Exhibitions
13.45 - 14.20
Conceptual design in the Pharma/Biotech industry Mr. Uri Doron
14.20 - 15.00
Quality aspects of a pharmaceutical project Dr. Sigalit Portnoy
15.00- 15.30
Coffee Break & Vendor Exhibitions
15.30 - 16.15
Case Study - Lessons from building a biopharmaceutical plant Mr. Zvi Ben-Hetz

*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)
For registration please click here (word doc.)
For more information or directions, contact Eilat at Forum Scientific Education Tel: 08-9409085
Fax:
08-9409086 E-mail: forum_co@netvision.net.il site: www.forumsci.co.il