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IPEA
GMP Three-Day
Houston Auditing Workshop - Houston, TX
September 23-25,
2008
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Registration
Fees
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Three-Day
Workshop
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Employees
of
IPEC
Member Companies
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$1850.00
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Nonmembers
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$2250.00
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*hotel
fees (not included)
8:00-9:00am Registration
8:30-9:00am Continental Breakfast
9:00-5:00pm Workshop Session
Workshop
Content
A
comprehensive three-day workshop in excipient
auditing for makers and users. Training
will analyze
the essential elements of excipient good
manufacturing practice for materials intended
for
use in pharmaceuticals, dietary supplements,
food
or as industrial chemicals and explains
how the applicable product standards differ.
The workshop
will focus on excipient GMP compliance and
attendees will learn auditing techniques,
report writing, observation classification,
etc. that relate to the manufacture of excipient
ingredients. The workshop contains exercises
to hone observation skills through participation
in a hands-on mock excipient GMP audit.
Participants will gain a thorough understanding
of risk-based excipient auditing and learn
how to assess whether an excipient GMP quality
system can achieve a satisfactory level
of compliance. Finally, attendees will learn
how to differentiate the requirements for
excipient manufacture from those of APIs.
Participants
who complete the course will have learned
how to plan, conduct and document excipient
manufacturing facilities for conformance
to excipient GMP standards as listed in
<1078> of USP/NF and in IPEC GMP Guidance.
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