A ONE-DAY SEMINAR

Organized by Alex Gulkarov and Gilad Bernadsky

Topics in Pharmaceutical Microbiology

Tuesday, November 20, 09:00 – 16:00h
at Lev Hakongressim, Weizmann Science Park, Ness Ziona

Program:

Duration	Topic	Speaker
09:15 – 09:30	Opening Remarks	Dr Raphy Bar, PDA President Organizers: Alex Gulkarov (Teva) and Dr. Gilad Bernadsky, (Teva)
09:30 – 10:00	The Place of the Microbiologist in the Pharmaceutical Industry	Karen Ginsbury PCI
10:00 – 10:30	Microbial Limit Test Harmonization	Alex Gulkarov Teva
10:30 – 11:00	Coffee Break
11:00–11:30	Sterility Test Validation – Pharmacopeias Overview	Mickol Reuveny Taro
11:30 – 12:00	Antimicrobiological Effectiveness Test: USP vs. EP Methodology and Validation	Dr. Galit Tzabary Aminolab
12:00 – 12:30	Microbiology and Water Activity	Lily Shay Teva
12:30 – 13:45	Lunch
13.45 – 14.15	Microbiological Aspects of validation of Sterilization by Ethylene Oxide and Gamma radiation	Harry Leinwand R&Q Consulting
14.15 – 15.00	Microbiological Laboratory Best Practice – The new USP chapter <1117>	Dr. Dudi Meraro Protalix
15.00 – 15.30	Coffee Break
15.30 – 16.00	Panel discussion	Seminar Speakers

WHO SHOULD ATTEND?

Microbiologists and laboratory technicians in QC and R&D laboratories in pharmaceutical companies for drug substances (APIs) and drug products.
QA and RA personnel involved in auditing and reviewing Microbiological methods and tests.
Pharmacists and formulators who want to understand microbilogical aspects in the pharmaceutical industry.
Anyone who wants to be updated on the recent regulatory status and the current practice related to the issue of microbiology in the pharmaceutical industry.

Participation: PDA members - 690 NIS
Non members - 885 NIS

Registration is mandatory, please register here

Organized & Produced by
Bioforum Applied Knowledge Center

Bioforum - Applied Knowledge Center
Lev Hakongressim, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail: bioforum@bezeqint.net
site: www.bioforum.org.il