Invitation to
PDA Discussion Meeting
Organized by Raphy Bar
On

Process Simulation
for Aseptically Filled Products (Media Fill)
(A newly revised Technical Report No. 22)

Presentation: PDA Technical Report 22:
Process Simulation for Aseptic Filled Products (PSA) - Media Fill

This document replaces the original PDA Technical Report 22 published in 1996 and therefore, the newly issued (2011) technical report reflects the continuing changes that have occurred in aseptic processing technology within the global industry. The updated document highlights considerations of risk to product sterility and patient safety as criteria for the design of the aseptic process simulation studies.

Wednesday, March 28, 2012
16:00 – 19:00h
15:30 - 16:00 - Registration

The Ayalon Institute (Machon Ayalon)
(Next to Park Weizman, Rehovot)

Parking inside Machon Ayalon is allowed!

Overview of the PDA Technical Report
(Revision 2)
by Galit Afik
Director of Quality Assurance, Manufacturing
Kamada

Actual Performance According to the Regulatory Requirements:
Considerations and Challenges
by Galit Afik
Director of Quality Assurance, Manufacturing
Kamada

A Questions & Answers session
will be held with the participation of
Rachel Shimonovitz
Head of the Inspectorate,
Institute for Standardization and Control of Pharmaceuticals
Israel MOH

The presentations and discussion will be held in Hebrew

Note: Unexpected changes that are beyond our control, may occur in the advertised program.

Participation: International PDA members - 80 NIS
Non members - 160 NIS

Registration is mandatory, please register here    

        for map please click here