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Israel PDA Chapter

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  1. Israel PDA Chapter By Raphy Bar

  2. Israel PDA Chapter • Was founded in 1997 by Karen Ginsbury, Karin Baer and Gil Bismuth • The Chapter promotes professional interaction between its members by bringing together pharmaceutical manufacturers, suppliers, users, academics and regulatory officials to exchange rapidly evolving information on the latest technology and regulations concerning high-quality pharmaceutical production and science in the interest of public health. • It is made up of the Executive committee, including the president, vice president, treasurer and Liaison, and more than 650 individual members

  3. 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. Members: 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

  4. The Parenteral Drug Association (PDA) The leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. 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.

  5. PDA has 23 Chapters around the world

  6. Chapters in the North America • Canada • Capital Area • Delaware Valley • Metro • Midwest • Mountain States • New England • Puerto Rico • Southeast • Southern California • West Coast • Chapters in Europe • Central Europe • France • Ireland • Israel • Italy • United Kingdom • Chapters in Asia-Pacific • Australia • India • Japan • Korea • Southeast Asia • Taiwan

  7. PDA Events • PDA Training and Research Institute (TRI) Courses • Conferences • Audio Conferences • Web Seminars

  8. PDA Publications • · PDA Journal of Pharmaceutical Science and Technology • · Monthly PDA Letter • · Technical Reports • · Books and Scientific Publications

  9. Science Advisory Board (SAB) 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.

  10. EVENTS OF ISRAEL PDA CHAPTER FOR 2007 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