1 Day Seminar
Oral presentations are given in Hebrew

Organized by:
Raphy Bar, BR Consulting, Pharma & Bio Pharma
Roni Cohen, Head of the Microbiology and Chemistry Department, HyLabs

As we are all expecting an upcoming revision of EU GMP Annex 1, quality control and assurance personnel, regulatory affairs personnel, production personnel and microbiologists exhibit an increasing interest in pharmaceutical microbiology and in monitoring controlled rooms. This seminar will present a mixture of new advances with traditional practices, all related to the controlled environments for production of drug products and medical devices.

After presenting the new changes in the revised ISO 14644 standard for classification of cleanrooms, the new paradigm of USP <1116> of assessing the microbiological quality of controlled rooms will be discussed and compared with the traditional regulatory limits. The novel technique of a continuous real-time monitoring of bio-particles in air will be presented as a potential substitute for the traditional growth-based counting of microbes. Finally, this seminar with present a case study on the practice of monitoring controlled rooms in a sterile product manufacturing facility and will review a systematic investigation of environmental monitoring excursions.

Seminar program:

Duration Topic Speaker
09:00-09:15 Registration
09:15-09:30 Opening Notes Karin Baer
President of PDA Chapter
09:30-10:10 Regulatory updates of ISO 14644 Parts 1 and 2 Noga Katar
10:10-10:50 New USP <1116> Approach: Contamination recovery rates
Raphy Bar
BR Consulting
10:50-11:30 Coffee Break
11:30-12:10 Rapid methods for enumeration of microbial counts:
Real time monitoring
Roni Cohen
12:10-12:50 Environmental Monitoring Policy and Implementation
in BTG-Ferring Pharmaceuticals
Galit Weil
Ferring (BTG)
12:50-13:50 Lunch
13:50-14:30 PQ of HVAC systems Drorit Lew
14:30-15:10 Investigating environmental monitoring excursions
Arik Livni
15:10-16:00 Panel discussion

Rachel Shimonovitz
Ministry of Health
& Seminar Speakers

Note: the program and speakers are tentative and subject to change without prior notice.

Target Audience:

Microbiologists, production managers, quality control managers, senior management, practitioners of environmental monitoring, QA personnel, RA personnel, and those involved in the preparation of the annual product review will benefit from attending this seminar.

Participation Fees:
PDA members - 650 NIS
Non members - 850 NIS 

Exhibit at the PDA event!



   For exhibition information please contact Reut at : reutl@bioforum.co.il


Organized & Produced by
Bioforum - Applied Knowledge Center
Golda Meir 3, 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