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.
           for map please click here

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