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Organized
by:
Raphy
Bar,
BR
Consulting,
Pharma &
Bio
Pharma
Roni
Cohen,
Head of the
Microbiology
and
Chemistry
Department,
HyLabs
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As we are all
expecting an
upcoming revision of
EU GMP Annex 1,
quality control and
assurance personnel,
regulatory affairs
personnel,
production personnel
and microbiologists
exhibit an
increasing interest
in pharmaceutical
microbiology and in
monitoring
controlled rooms.
This seminar will
present a mixture of
new advances with
traditional
practices, all
related to the
controlled
environments for
production of drug
products and medical
devices.
After presenting the
new changes in the
revised ISO 14644
standard for
classification of
cleanrooms, the new
paradigm of USP
<1116> of
assessing the
microbiological
quality of
controlled rooms
will be discussed
and compared with
the traditional
regulatory limits.
The novel technique
of a continuous
real-time monitoring
of bio-particles in
air will be
presented as a
potential substitute
for the traditional
growth-based
counting of
microbes. Finally,
this seminar with
present a case study
on the practice of
monitoring
controlled rooms in
a sterile product
manufacturing
facility and will
review a systematic
investigation of
environmental
monitoring
excursions.
Seminar
program:
Note:
the
program
and
speakers
are
tentative
and
subject
to
change
without
prior
notice.
Target
Audience:
Microbiologists,
production
managers,
quality control
managers, senior
management,
practitioners of
environmental
monitoring, QA
personnel, RA
personnel, and
those involved
in the
preparation of
the annual
product review
will benefit
from attending
this seminar.
Participation
Fees:
PDA members -
650 NIS
Non members -
850 NIS
Exhibit
at the PDA
event!
Exhibitors:
For exhibition
information
please contact
Reut at : reutl@bioforum.co.il
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