ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent 2019
23 May 2019
Webinar
Description
ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent 2019 is an event dedicated to the background of all sections of ICH Q7 guidance and key critical section contents.
Topics
What caused ICH to take action?
Why was there a need to write API GMP even though Drug Product GMP (21 CFR Part 210 and 211) already existed?
Who participated and why?
How was this need address initially and finally?
KEY Sections
Identify Sections of Q7
How to apply Q7
Important parts of Key Sections
Who should Attend
Drug intermediates, excipients, developing, or registration of these with FDA.
Producing, testing, storing or distributing API
Repacker or Relabelers of API
Managers, site managers, Production, Quality, Development, Maintenance, Storage/Distribution Management of API Firms.
Past Events
ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent 2019 - 23 May 2019, Webinar (84586)
Important
Please, check "ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent" official website for possible changes, before making any traveling arrangements
