Description
It is essential that API production facilities operating under
local regulatory authorities in different regions consistently
produce the same API that meets the quality attributes and
characteristics it is intended to have. An Expert Working
Group developed the ICH-Q7A document as a single
standard that all suppliers should apply to production of APIs
used in human products manufactured in any of the ICH
signatory regions. This course also includes sections on APIs
produced by cell culture/fermentation and on APIs used in
clinical trials.<br><br>
The course will provide historical insight and specific
interpretation of the requirements in the Q7A document. The
Q7A document addresses all aspects of API production in 19
sections and each of these sections will be critically examined
in detail during the course. At the end of the first day is a
discussion period between faculty and registrants to clarify
points and exchange information with colleagues. Also
included is a workshop in which registrants are asked to apply
what they have learned to resolve issues in test cases based
on actual FDA-483 observations.
01/01/0001
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Clinical Research Organization
Course Category
Address
Amsterdam
Amsterdam,