A ONE-DAY SEMINAR on
עיקור באוטוקלב בתעשיה הפרמצבטית


Monday 24 of March 2008
Lev Hacongressim, Nes-Ziona


Organized by Eitan Gross

A one-day seminar dedicated to a systematic approach towards understanding
and implementing the processes of moist Heat Sterilization with reference
to the newly published updated PDA Technical Report 1

       Program:

Duration Topic Speaker
09:15 – 09:30
Opening Remarks Dr Raphy Bar
PDA Israel Chapter President
09:15 – 10:00
Review of updated PDA Technical Report

Eitan Gross
Kamada

10:00 – 10:45
Moist Heat Sterilization - Process Development
Micha Saroya
Mediplast

10:45 – 11:15
Coffee Break

11:15–11:55

Validation of Moist Heat Sterilization

Izio Akerman
Teva

11:55 – 12:25
Moist Heat Sterilization: Case Studies

Alex Garbarnik
Rafa Laboratories

12:25 – 13:00 Regulation Requirements for Qualification of Biological Indicators

Orly Peter
Rafa Laboratories

13:00 – 14:00
Lunch
14:00 – 14:40
Review of Chemical & Biological Indicators for Moist Heat Sterilization process

Aviad Val
Chemitec

14:40 – 15:20
Engineering & Quality aspects for new sterilizer
Arnan Ben David
Omrix

15:20 15:50
Coffee Break
15:50 – 16:30
New Trends & Technologies in Moist Heat Sterilizers Tamir Schwartz
Tasgiv Engineering

16:30 – 17:00

Panel discussion
Seminar Speakers

         WHO SHOULD ATTEND?

  • Validation Engineers who prepare and perform validation studies for moist heat
    Sterilization processes.
  • Production Engineers/operators who design moist heat sterilization processes.
  • Microbiologists and laboratory technicians in QC and R&D laboratories in pharmaceutical and biopharmaceutical companies, who test biological indicators for validation of Autoclaves.
  • QA personnel involved in auditing and reviewing moist heat sterilization processes.
  • Pharmacists who want to have deeper understanding of the moist heat sterilization process
  • Anyone who wants to be updated on the recent regulatory guides and the current practice related to the issue of moist heat sterilization (including cycle design , development , qualification and ongoing control).
           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