IPEA GMP Three-Day
Auditing Workshop
Prague, Czech Republic
April 27 - 29, 2009
Registration Fees |
Three-Day Workshop |
Employees of
IPEC
Member Companies |
|
Nonmembers |
2500.00 USD
1800 EUR |
*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 principles as listed in <1078> of USP/NF and in IPEC GMP Guidance.
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