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Israel PDA Chapter

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Was founded in 1997 by Karen Ginsbury, Karin Baer and Gil Bismuth. The Chapter promotes professional interaction between its members ... – PowerPoint PPT presentation

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Title: Israel PDA Chapter


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
PresidentRaphy 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 , RD 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
SEMINARGenotypic Methods for Detection and
Identification of Microorganisms in
pharmaceutical Environment and Biological
ProductsJuly 9, 2007
SEMINARQuality 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
Guidance February 7, 2007
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