Tuesday, September 4, 09:00 – 16:00h
Machon Ayalon, Rehovot

Organized by Raphy Bar and Sasha Nezlin


Duration Topic Speaker
09:00 - 09:30
09.30 – 09:45 Opening Remarks Rina Yamin
PDA Chapter President
09.45 – 10.15 Handling of OOS – The Inspector's point of view Sarah Covrigaro
Institute for Standardization
and Control of Pharmaceuticals
Ministry of Health

10.15 – 10.45 Handling an OOS in a QC Lab  Sasha Nezlin
Senior QA Manager
Omrix Biopharmaceuticals
10.45 – 11.15 Coffee Break
11.15 – 12.00 Uncertainty of Results and the impact of OOS Etty Feller
Head of Israel Laboratory
Accreditation Authority
12.00 – 12.30 Non-conforming test results in R&D Alex Mirimsky
Head of Analytical R&D, CTS
Anat Puter
R&D QA Manager, CTS
12.30 – 13.00 A statistical procedure for determining number of retests in case of OOS Drorit Lew
VP Quality, Production Plant, Kamada

13.00 – 14.00 Lunch
14.00 – 14.45 Statistical treatment of unexpected results: Case studies Oren Bar-Ilan
Head of Non-clinical Statistics GBP, Teva-Abik
14.45 – 15.15 Handling Deviations in the Microbiological Laboratory Orly Hammer, Ph.D.
Microbiological Laboratories Manager
Omrix Biopharmaceuticals

15.15– 16.00 Panel discussion Seminar Speakers;
Raphy Bar, Ph.D.

Note: Please Note the speakers and topics were confirmed at the time of publication. However, circumstances may necessitate substitution, alteration or cancellation of speaker and / or topic, without prior notice


  • Analytical chemists and laboratory technicians in QC and R&D laboratories in pharmaceutical companies
  • QA and RA personnel involved in auditing and reviewing analytical data
  • Pharmacists and formulators who want to understand how to handle deviations in the pharmaceutical process
  • Anyone who wants to be updated on the recent regulatory status and the current practice related to the issue of handling unexpected test results
  • Management personnel who wants to understand why a batch of drug product might be rejected

Participation fees:
PDA members - 750 NIS
Non members - 950 NIS

Registration is mandatory, please register here

      For map please click here

        Free parking is available inside Machon Ayalon

Organized & Produced by
Bioforum - Applied Knowledge Center
Golda Meir 5, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail: bioforum@bioforum.co.il
site: www.bioforum.co.il