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Newark Excipient Auditing Workshop
Tuesday June 8 - Thursday June 10, 2010
Registration Fees |
Three Days |
Employees of
IPEC-Americas
Member Companies |
$1850 |
Nonmembers |
$2250 |
Government |
$600 |
*hotel fees (not included)
Three day Workshop
Content
A
comprehensive 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 or dietary supplements.
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 including 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. Hear the latest concerning Excipient GMP Conformance Certification.
Participants
who complete the course will have learned
how to plan, conduct and document an audit of 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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