ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent

ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent is an online event dedicated to the background of all sections of ICH Q7 guidance and key critical section contents.

ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent covers topics such as:

  • 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

ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent intended for:

  • 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.

Future Events

ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

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