Forum Bio-Log: www.forumsci.co.il
Hilton Hotel, Tel Aviv

Organised by Dr. Raphy Bar (Pharmos)


Topic
Duration
Speaker
Registration
09.00 - 09.15
 
Opening Remarks
09.15 - 09.25
PDA President – Dr. Sigalit Portnoy (Taro)
09.25 - 09.30
Seminar Organizer
Regulatory aspects as reflected in the new USP 2005 and FDA Sterile Guide
09.30 - 10.00
Karen Ginsbury (PCI Ltd)
Validation of Microbial Limit test
10.00 - 10.30
Dr. Dudi Meraro (Taro)
Coffee Break
10.30 - 11.00
 
Validation of sterility test methods
11.00 - 11.30
Alex Gulkarov (Teva)
Validation of new microbiological methods

11.30 - 12.00

Dr. Ofer Dubinsky (BTG)
Validation of bactericidity of disinfectants
12.00 - 12.30
Dr. Lily Shay (Teva)
Lunch
12.30 - 13.30
 
Statistical aspects of microbial counts
13.30 - 14.00
Oren Bar-Ilan (Tmura)
Microbiological testing of Medical Devices
14.00 - 14.30
Yehudith Wexler (Forum-Biolog)
Coffee Break
14.30 - 15.00
 
Bacterial Endotoxins: validation of turbidometric method
15.00 - 15.30
Eli Solomon (IMT)
Bacterial Endotoxins: validation of gel-clot method
15.30 - 16.00
Judith Bahar (hy-labs)
Panel discussion
16.00 - 16.30
Ashbel Best (Teva) and Seminar Speakers
Who should attend?
Laboratory personnel in QC and R&D laboratories in pharmaceutical and biopharmaceutical companies, who determine the microbiological quality of drug substances, drug products and medical devices.
Laboratory personnel in QC and R&D laboratories in pharmaceutical and biopharmaceutical companies, who determine the content of bacterial endotoxins of water systems, drug substances, drug products and medical devices.
Laboratory personnel in QC and R&D laboratories in pharmaceutical and biopharmaceutical companies, who validate microbiological methods or bacterial endotoxins methods.
QA and RA personnel involved in auditing and reviewing test data.
Pharmacists and formulators who want to gain insight into the microbiological testing of pharmaceutical products
Anyone who wants to be updated on the latest regulatory status of microbiological testing.
Anyone who wants to know how different companies handle the important issue of microbiological method validation.
Participation Fees:
590 NIS for PDA members
840 NIS for new members including electronic international PDA membership
1040 NIS for new members including full international PDA membership
Click here for a registration form
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