Israel PDA Chapter By Raphy Bar Israel PDA Chapter Was founded in 1997 by Karen Ginsbury, Karin Baer and Gil Bismuth
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President:Raphy Bar , Senior Director of Analytical Development, Pharmos
Vice President: Moti Izhar , Validation Department Manager, Ludan Engineering, Beer Sheva
Treasurer:Karin Baer , Director of Quality Assurance, Omrix biopharmaceuticals Ltd Chapter Liaison, Karen Ginsbury President of PCI Pharmaceutical Consulting Israel Ltd.
Gilad Bernadsky , Technological and Scientific Affairs (TSA) Manager, Teva Einat Frydman Quality Assurance Manager, Teva
Sigalit Portnoy-Arieli Oral Solid Dosage Forms, Kfar-Saba Plant, TevaEitan Gross , Quality Manager - QE & Projects, Kamada
Rachel Karpel , Senior Associate, PCI Pharmaceutical Consulting Israel Ltd. Rina Yamin , R&D Manager , CTS Industries
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Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide.
The PDA Science Advisory Board (SAB) establishes the strategic direction and provides oversight for PDA's scientific and technical activities through the development of guidelines, technical reports, and technical bulletins.
Biotechnology Advisory Board ( BioAB)
It is a critical source for identifying biotechnology issues of interest to PDA members globally.
Regulatory Affairs and Quality Committee (RAQC)
Review and comment on regulatory documents issued by agency/organization (i.e., FDA, EMEA, WHO etc…)
Representative from Israel Chapter: Karen Ginsbury.
SEMINAR:Genotypic Methods for Detection and Identification of Microorganisms in pharmaceutical Environment and Biological ProductsJuly 9, 2007
SEMINAR:Quality by Design and Risk Management in the Pharmaceutical and Biopharmaceutical IndustriesApril 17 2007
DISCUSSION MEETINGCurrent Trends in CAPA ManagementMay 14 2007
DISCUSSION MEETINGOut-of-Specification (OOS) FDA GuidanceFebruary 7,2007