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Hilton
Hotel, Tel Aviv |
Organised by Dr. Moti
Izhar
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| Topic
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Duration
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Speaker |
| Registration |
08.30
- 09.00 |
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| Opening
Remarks |
09.00
- 09.15 |
PDA President
– Dr. Sigalit Portnoy (Taro)
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| Introduction
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| Cleaning validation
- regulatory point of view |
09.15
- 10.00 |
Dr. Rachel Karpel, MOH |
| Cleaning VMP |
10.00 -
10.45 |
Dr. Moti Izhar, Ludan Engineering |
| Coffee
Break |
10.45
- 11.00 |
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| Cleaning
Methods |
| CIP - Automatic cleaning strategies |
|
Moshe Landsberg |
| Cleaning Validation for Biological
products - Manual versus CIP |
11.45 - 12.30 |
Karin Baer, Omrix |
| Lunch
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12.30
- 13.30 |
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| Sampling
Methods |
| Sampling : relations
between formulation and recovery of active
compound |
13.30 -
14.15 |
Dr. Tanya Gershanik, Taro |
| Microbial aspects
of cleaning validation |
14.15 -
15.00 |
Dr. Dudi Merro, Taro |
| Coffee
Break |
15.00
- 15.15 |
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| Acceptance
criteria |
| Acceptance criteria and residues
calculation |
15.15
- 16.00 |
Dr. Baruch Magenheim Agis |
| Forum
Q&A |
16.00
- 17.00 |
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Who should attend? |
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Production,
QA and RA personnel involved in
production of: Sterile or Non-Sterile
pharmaceutical or biopharmaceutical
production activities, APIs and
intermediates. |
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Laboratory
personnel in QC and R&D laboratories
in pharmaceutical and biopharmaceutical
companies, who develop analytical
methods for cleaning validation
for production, drug substances,
drug products and medical devices. |
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Laboratory
personnel in QC and R&D laboratories
in pharmaceutical and biopharmaceutical
companies involved in validation
processes. |
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Engineering
and technical personnel designing
pharmaceutical equipment. |
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Pharmacists
and Formulators who want to gain
insight into the residues and carry
over issues (chemical and microbiological)
pharmaceutical products |
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Anyone who
wants to be updated on the latest
cleaning policies, technologies,
sampling methods, analytical methods
and acceptance criteria. |
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Anyone who
wants to know how different companies
handle the important issues of policies,
technologies, sampling methods,
analytical methods and acceptance
criteria used for cleaning validation. |
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Participation
Fees:
590 NIS for PDA
members
840 NIS for new members including electronic
international PDA membership
1040 NIS for new members including full
international PDA membership |
| Click
here for a registration form |
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