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2019 - ICH Q7 FDA Guidance – Its Structure, History, Application and Writer's Intent

Date2019-08-15

Deadline2019-08-15

VenueOnline Event, USA - United States USA - United States

KeywordsIch q7 guidelines; Ich q7 training; Fda q7 guidance

Websitehttps://www.complianceonline.com/ich-q7-...

Topics/Call fo Papers

Why was there a need to write API GMP even though Drug Product GMP (21 CFR Part 210 and 211) already existed?
What caused ICH to take action?
How was this need address initially and finally?
Who participated and why?
Identify Sections of Q7
Discuss KEY Sections
Examine important parts of Key Sections
Discuss how to apply Q7
Opportunity to ask specific questions about Q7 that is not obvious in this oversite webinar.

Last modified: 2019-07-02 05:17:51