PDA SEMINAR

Organized by: Dr. Rachel Karpel

On





Lev Hakongressim, Weizmann Science Park, Ness Ziona

PROGRAM FOR PDA SEMINAR

November 18, 2008

Duration	Topic	Speaker
09.00– 09:15	Opening remarks	Dr. Rachel Karpel, PCI Dr. Raphy Bar, President of PDA Israel Chapter
09:15– 10:00	Calibration in the pharmaceutical Industry	Arnan Ben David Omrix
10:00 – 10:45	Basic requirements from in house and external calibration laboratories	Teddy Hoffman ISRAC Consultant
10.45– 11:15	Coffee Break
11:15– 12.00	Qualification of equipment and systems – Current Regulatory requirements	Dr. Mordechai Izhar Ludan Engineering
12.00 – 12:45	ASTM E2500 - 07 Standard: A New Approach for Commissioning & Qualification of Equipments and Systems	Ronen Sarusi Teva
12:45– 13:45	Lunch
13:45– 14.30	Qualification of Bioreactors	Dr. Yehoshua Aloni Teva
14:30 – 15:15	A Practical Approach to Programmable Logic Controllers (PLC) and HMI Validation	Ido Cohen Protalix
15.15– 15:45	Coffee Break
15:45 – 16.30	Qualification of HVAC systems	Eitan Gross Medimop
16:30– 17.00	Panel Discussion	Seminar Speakers

WHO SHOULD ATTEND?

• Validation Engineers who prepare and perform equipment/system qualification studies
• Production personnel involved in preparation and reviewing of equipment/system qualification studies
• Maintenance personnel involved in calibration
• Quality Assurance personnel involved in auditing and reviewing of validation studies
• Quality Assurance personnel involved in qualification and auditing of calibration laboratories
• Anyone who wants to be updated on the recent regulatory guides and the current practice related to calibration and qualification of equipment and systems.

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

Registration is mandatory, please register here