| PDA ISRAEL
ANNUAL MEETING |
| Presidents welcome, Karin Baer, VP Quality, Neuroderm
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| Artificial Intelligence in Pharma: FDA and EMA regulatory
perspective, Iris Shamir, VP Pharmaceutical Quality and Medical Device,
GSAP |
| How AI will shape the future of Quality & Compliance,
Doron Sitbon and Yuval Nardi, Dot Compliance |
| Israel
MOH presentation, Rachel Shimonovitz, Head of GMP Directorate, Israel
MOH |
| GMP Related Updates and Hot Topics (EU/US), Gil Zomber,
Gil Pharma Consulting
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| Gallery of Annual Meeting
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| PDA Past
Activities: 2024 |
Demonstration of Comparability of Alternative
Analytical Procedures
10 April 2024
For more information please click here |
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For more information please click here |
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| PDA Past
Activities: 2023 |
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PDA Israel Live Online Webinar
Develop, Validate and
Verify Analytical Procedures
July 12, 2023
For more information please click
here
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PDA Israel FREE Webinar
Post COVID FDA Inspections
What has changed?
March 30, 2023
For more information please click here
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| PDA Past
Activities: 2022 |
Annual
Meeting of The Israel Chapter of PDA
April 26, 2022, Kfar Hamaccabiah
For more
information please click here
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PDA Israel FREE Webinar
Quality Metrics and KPIs
March 20, 2022
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| PDA Past
Activities: 2021 |
PDA
Israel FREE Webinar
Control of Nitrosamine Impurities
June 16, 2021 |
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PDA
Israel FREE Webinar
Pre Use/ Post Sterilization Integrity Test PUPSIT
March 24, 2021 |
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PDA Israel FREE Webinar
Audits & Inspections
during Covid-19
January 19, 2021 |
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| PDA Past
Activities: 2020 |
PDA
Israel FREE Webinar
Data Integrity
Concepts and Challenges
by
Galit Lisaey, Gal.IT Data Integrity Consulting
September 6, 2020 |
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PDA Israel FREE Webinar
Evaluation of Extractables & Leachables (E&L)
From Product Contact Items (PCIs)
Leo Brenman, M.Sc.
Quality Unit Compliance Associate & Tech. Writer
Bio-Technology General
August 17, 2020
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PDA
Israel FREE Webinar
EU GMP, Annex 1:
Manufacture of Sterile Products Revision
Organized by Galit Afik
July 19th, 2020 |
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PDA Free
Webinars
June 2020
Cold WFI Production, Beyond Distillation.
How and What
Drug Shortage and Supply ChainIssues
Lifecycle Management of Analytical Procedures and Analytical QbD
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One
Day PDA Seminar
Combination products – Updated
guidelines and regulations
February 3, 2020
For more information
please click here
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| PDA Past
Activities: 2019 |
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Annual
Meeting of The Israel Chapter of PDA
December 30, 2019, The David
Intercontinental Hotel, Tel-Aviv
For more
information please click here
Gallery of Annual Meeting 2019
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One
Day PDA Seminar
New Developments in Water
Systems
May 5, 2019
For more
information please click here
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One Day PDA Seminar
Technology Transfer and Working with CMO-CDMO
March 4, 2019
For more
information please click here
Presentations
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| PDA Past
Activities: 2018 |
Annual
Meeting of The Israel Chapter of PDA
December 25, 2018, The David
Intercontinental Hotel, Tel-Aviv
For more
information please click here
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One Day PDA Seminar
Key areas for strategic drug development
planning:
Meet with the Israeli MOH, Innovation Authority and the pharmaceutical
Industry leaders
Organized by Meir Batito and Shlomo Sackstein
October 24, 2018
Kfar Maccabiah, Ramat Gan
For more information please click here
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Half Day PDA Seminar
Active Pharmaceutical Ingredients
Physical Characteristics and Polymorphism
Organized by Raphy Bar and Judith Aronhime
October 8 2018
Hagana Hall,
Ayalon Institute,
Ness Ziona
For more information please click here
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1 Day Seminar
Understanding the
new draft of Annex 1
with the participation of the
MOH and Industry!
5 September 2018
Kfar Maccabiah, Ramat Gan
For more information please click
here
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One day seminar:
Use of “Single Use Systems” the Technology of the 21st
Century
7 May 2018
For more information please click
here
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One day seminar:
Serialization
March 7, 2018 |
| PDA Upcoming
Activities: 2017 |
|
Annual
Meeting of The Israel Chapter of PDA
December 26, 2017, The David Intercontinental Hotel,
Tel-Aviv
For more information please click
here |
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| PDA Past
Activities: 2017 |
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One day
seminar: Autoclaves and Lyophilizers
13 November 2017
For more information please click here |
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One
day seminar: Data
Integrity
30 July 2017
For more information please click here |
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One
day seminar: Sterile
filling
technology
May 16, 2017
For more information please
click here
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Annual
Meeting of The Israel Chapter of PDA
January 15, 2017, The David Intercontinental Hotel,
Tel-Aviv
For more information please click
here
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| PDA Past
Activities: 2016 |
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One day seminar:
Environmental Monitoring of Controlled Rooms
28 November 2016
For more information please click
here
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PDA
Discussion Group: Problem Solving Methodology
26 July 2016, Teva Kfar Sava
For more information please click
here
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One day seminar: The new EU
Requirements
for performing Risk Assessment for excipients
8 June 2016, Ayalon Institute, Rehovot
For more information please click
here
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One day seminar: Flexibility
– a key element for improvement
April 17, 2016,
Krypton Ayanot
For more information please
click here
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| PDA
Past Activities: 2015 |
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Annual Meeting of The Israel Chapter of
PDA
December 20, 2015, The David Intercontinental Hotel,
Tel-Aviv
Gallery
For more information please
click here
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Design &
Operation of PW
Production & Storage
23 November 2015
Kfar Maccabiah, Ramat Gan
For more information please click here
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PDA Europe Conference
30 June - 1 July 2015
The Sheraton hotel, Tel Aviv, Israel
For more information please click here
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CFR 21 Part
11
29 January 2015
Kfar Maccabiah, Ramat Gan
For more information please click here
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| PDA Past
Activities: 2014 |
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Annual
Meeting of The Israel Chapter of PDA
December 30, 2014, The David Intercontinental Hotel,
Tel-Aviv
For more information please click
here |
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Combination
Product
7 September 2014
Kfar Maccabiah, Ramat Gan
For more information please click here
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Trend Analysis
24 July 2014
Kfar Maccabiah, Ramat Gan
For more information please click
here
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GMP Updates in Engineering and Maintenance
January 22, 2014, Kfar Hamakabbiah, Ramat Gan
click
here for more.. |
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| PDA
Past Activities: 2013 |
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Annual Meeting of The Israel Chapter of
PDA
December 23, 2013, The David Intercontinental Hotel,
Tel-Aviv
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here for more..
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Cleaning Validation and Shared Facilities
by Destin LeBlanc
12 - 13 November 2013
Kfar Maccabiah, Ramat Gan
click
here for more.. |
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Training Course
-
An Introduction to Visual Inspection
11-12 March 2013
click
here for more..
Gallery
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| PDA Past
Activities: 2012 |
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PDA
Seminar On:
Process Analytical Technology (PAT) and FDA
Directives
by Dr. Shib Mookherjea, USA
27 December 2012
click
here for more..
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PDA Seminar
On:
Methods Development and Validation with a scientific approach and Risk
based Strategy
by Dr. Shib Mookherjea, USA
26 December 2012
click
here for more.. |
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Annual Meeting of The Israel Chapter of
PDA
December 24, 2012, The David Intercontinental Hotel,
Tel-Aviv
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here for more..
Gallery
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PDA Seminar On:
In use stability studies
29 November 2012
The Ayalon Institute
click
here for more..
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PDA Seminar On:
Non-Conforming Test Results in the Pharmaceutical
Industry
4 September 2012
The Ayalon Institute
click
here for more..
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PDA Packaging
Seminar
June 5, 2012
The Ayalon Institute
click
here for more..
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PDA Discussion
Meeting
Process Simulation for Aseptically Filled Products
(A newly revised Technical Report No. 22)
March 28, 2012
The Ayalon Institute
click
here for more..
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Annual Meeting of The Israel Chapter of
PDA
January 3, 2012, The David Intercontinental Hotel,
Tel-Aviv
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here for more..
Gallery
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| PDA Past Activities:
2011 |
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PDA Training and
Research Institute (TRI) courses in Israel:
Applied Statistics in Process
Validation and Ongoing Product / Process Performance Monitoring
November 7-8 2011
click
here for more..
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Discussion Meeting on:
Development and Manufacture of Drug Substances
26 July 2011, Lev Hakongressim,
Weizmann Science Park, Ness Ziona
click
here for more..
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PDA
Seminar
On:
Systematic approach for Corrective & Preventive Action
13
June 2011, Lev Hakongressim, Weizmann Science
Park, Ness Ziona
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PDA Discussion Meeting
Quality Agreements in the Pharmaceutical Industry
3 May 2011,
Lev Hakongressim, Weizmann Science Park, Ness Ziona
click
here for more.. |
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Pharmaceutical
Development: Technological and Regulatory
Perspectives
17 March 2011, Kfar Hamaccabiah, Ramat
Gan
click
here for more.. |
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Microbiological Update
From Jeanne
Moldenhauer
7 -8
February, 2011, The David
Intercontinental Hotel, Tel Aviv
click
here for more..
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Annual Meeting of The Israel Chapter
of PDA
January 10, 2011,
The David Intercontinental Hotel, Tel-Aviv
click
here for more..
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| PDA Past Activities: 2010
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2-Day Course
Good Controlled
Temperature, Packaging, Transportation, and Storage Practices
December 21-22, 2010
Lev
Hakongressim, Weizmann Science Park, Ness Ziona
click
here for more..
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One-Day
Seminar
on
QC Laboratory in the Pharmaceutical Industry:
Current Topics
November 4, 2010, Kfar Hamaccabiah, Ramat Gan
click
here for more.. |
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One-Day
Seminar
on
Pharmacovigilance
July 18, 2010
click
here for more.. |
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Half Day Seminar
ICH Q9, Q10
The Pharmaceutical Quality System and Risk Management
Sunday March 21, 2010
click
here for more..
click
here for Pictures from Seminar...
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Annual Meeting of The
Israel Chapter of PDA
3 January 2010,
The Shefayim Conventions Center
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here for more..
Gallery
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| PDA Past Activities: 2009
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PDA Discussion Meeting On
Pharmaceutical Excipients: Qualification of Manufacturers, Regulations and
Security of Supply chain
October 27, 2009
click
here for more..
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FIRST PDA COURSE OF
THE TRAINING RESEARCH INSTITUTE (TRI)
QUALITY RISK MANAGEMENT
July 6 and 7, 2009
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SECOND
PDA COURSE OF THE TRAINING RESEARCH INSTITUTE (TRI)
PROCESS VALIDATION
July 8 and 9, 2009
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One-Day Seminar on DISSOLUTION TOPICS
Monday, June 22
click here for
more.. |
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A DISCUSSION
MEETING on
Pharmaceutical Supply Chain:
Updates from a recent PDA Meeting (Munchen, March 2009)
Monday May 18
click
here for more..
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A DISCUSSION MEETING on
HARMONIZATION OF MICROBIAL ENUMERATION METHODS
Thursday, March 26
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here for more..
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| PDA Past Activities: 2008
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Annual Meeting
of the Israel Chapter of PDA
December 10, 2008, David
Intercontinental Hotel, Tel-Aviv
click
here for
more..
Gallery:
Annual
Meeting of the Israel Chapter
of PDA -
2008
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1-Day
PDA Seminar on Calibration and Qualification of Equipment
and Systems in the Pharmaceutical Industry
November 18, 2008
click
here for more.. |
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PDA Discussion Group
on: The New Israeli GMP Legislation and the Harmonisation
Process
Sunday, October 26, 2008, 16:00h
click here for
more..
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Meet the FDA!
At the 2-Day PDA Seminar on Impurities in Drugs: Monitoring, Safety
and Regulations
July 15-16, 2008
click here
for more..
Gallery of the PDA
Seminar on Impurities in Drugs: Monitoring, Safety and Regulations
Presentation
of Dr. David Jacobson-Kram
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One Day Seminar on Pharmaceutical Water Systems
14 May 2008, Kfar Hamacabbiah, Ramat Gan
click
here for more..
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Discussion Meeting on:
Discussion Meeting on Manufacture of Sterile Medicinal Products REVISED
ANNEX 1 of EU GMP
5 May 2008, Lev Hakongressim, Ness Ziona
click
here for more.. |
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Discussion Meeting on: RISK
MANAGEMENT IS BECOMING MANDATORY!
Sunday April 6, 2008, Lev Hacongressim, Rehovot
click
here for
more..
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A one-day PDA Seminar: Moist Heat
Sterilization "Autoclaving"
Monday 24 of March 2008, Lev Hacongressim,
Rehovot
click
here for
more..
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| PDA Past Activities: 2007
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Annual Meeting of the Israel Chapter
of PDA
December
16, 2007, David
Intercontinental Hotel, Tel-Aviv
click
here for more..
Gallery:
Annual Meeting of the Israel Chapter of
PDA -
2007
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A one-day PDA
Seminar: TOPICS
IN PHARMACEUTICAL MICROBIOLOGY
November
20, 2007, Lev Hakongressim, Weizmann
Science Park, Ness Ziona
click
here for
more..
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A DISCUSSION MEETING of
The Israel Chapter of PDA: BLEND
UNIFORMITY
November
7, 2007, Lev Hakongressim, Weizmann
Science Park, Ness Ziona
click
here for
more..
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A
one-day PDA Seminar: STABILITY TESTING OF PHARMACEUTICALS
October 22,
2007, Lev
Hakongressim, Weizmann Science Park, Ness
Ziona
click
here for
more..
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A
Special Discussion Meeting on Regulatory Affairs
and Pharmaceutical Management in Central and Eastern
Europe
September 17, 2007, Lev
Hakongressim,
Weizmann Science Park, Ness Ziona
click
here for
more..
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Discussion
Meeting on GENOTYPIC
METHODS FOR IDENTIFICATION AND DETECTION OF MICROORGANISMS
FROM PHARMACEUTICAL ENVIRONMENT
Monday,
July 9, 2007, Lev
Hakongressim,
Weizmann Science
Park, Ness Ziona
click
here for
more..
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A ONE-DAY SEMINAR on COMBINATION
PRODUCTS AND MEDICAL DEVICES
Development and manufacturing considerations, Quality
Assurance and Regulations
Monday,
July 2, Lev
Hakongressim, Weizmann Science Park, Ness Ziona
click
here for
more..
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Discussion
Meeting of PDA: Current Trends in CAPA
Management
May
14 2007, Lev
Hakongressim, Weizmann Science Park, Ness Ziona
click
here for
more..
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Seminar: Quality
by Design and Risk Management in the Pharmaceutical
and Biopharmaceutical Industries
April 17
2007, Lev
Hakongressim, Weizmann Science Park, Ness Ziona
click
here for
more..
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DISCUSSION MEETING:
Out-of-Specification
(OOS) FDA Guidance
February
7, 2007,
Teva
- Kfar S
aba
click
here for
more..
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| PDA Past Activities: 2006
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Annual Meeting of the Israel Chapter of PDA
December
24, 2006,
Dan Panorama Hotel, Tel-Aviv
click here for
more..
Gallery: Annual Meeting
of the Israel Chapter
of PDA -
2006
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2006 Conference: From R&D
to Market: Technology Transfer
September 12, 2006, Lev
Hakongressim, Weizmann Science Park, Ness Ziona
click here for
more..
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Current issues in
Quality and Manufacturing of Biotechnology Products
August 13, 2006, kfar
Hamaccabiah, Ramat Gan
click here for
more.. |
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PDA Discussion
Group - Using Contract Manufacturing - Main Aspects and Considerations
June 13th, Cure Medical
Manufacturing, Emek Hefer Industrial Park
click
here for more.. |
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Controlled
Rooms for a Pharmaceutical Manufacturing Environment:
Construction, Maintenance and Regulation
March 30, 2006, Dan Panorma Hotel, Tel Aviv
click
here for
more.. |
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PDA Discussion Group
- New FDA Draft Guidance: INDs - Approaches to Complying
with CGMP during Phase 1
March 8, 2006 , Teva, Kfar Saba
click here for
more.. |
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| PDA Past Activities: 2005
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2005 Annual
Meeting
December 27, 2005, Dan Panorama Hotel, Tel Aviv
click
here for more.. |
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PDA Seminar -
Gap Analysis, EU vs. USA cGMP Requierments
November 9th, 2005, kfar Hamaccabiah, Ramat Gan
click here for
more.. |
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PDA Discussion
Group - Extractables and Leachables from Pharmaceuticals
September 28th, 2005, Teva, Kfar Saba
click here for
more.. |
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One-Day
PDA Seminar: Supply Chain Management and Industrial Engineering
in Pharmaceutical and Biotechnology Industry
July 11th, 2005 , 9:00-17:00 Hilton Hotel, Tel Aviv
click here for more..
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One-Day
PDA Seminar: Validation of microbiological methods in the pharmaceutical
and biopharmaceutical laboratories
June 2nd, 2005, Hilton Hotel, Tel
Aviv
click here for more.. |
|
PDA Discussion
group: New guideline document published by the
EMEA
May 16, 2005, BTG Rehovot
click here for more..
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One-Day
PDA Seminar: Cleaning Validation
April 12, 2005, Hilton Hotel, Tel Aviv
click here for more.. |
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PDA Discussion
group: ICH Q8 Pharmaceutical Development Guideline
March 17, 2005, Teva Kfar Saba
click here for
more..
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PDA Past
Activities: 2004
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Analytical
standards in Pharmaceutical and
Biopharmaceutical laboratories
November 2nd, 2004 ,Hilton Hotel, Tel Aviv
click here for more..
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Designing a
pharmaceutical / biotech facility for regulatory compliance
April 22nd 2004, Hilton Hotel, Tel Aviv
click here for more..
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Meet the regulator!
How to prepare for a European authorities inspection
March 2nd 2004, Hilton Hotel, Tel Aviv
click here for more..
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