Understanding cGMPs — What Attorneys Need to Know


Wednesday, July 10, 2013 | Alston + Bird LLP | Washington, DC



General Information



FDLI’s Understanding cGMPs conference was featured in the August 2013 issue of
The Gold Sheet.

Download a free copy of the article, “Justice Targets ‘Serious’ GMP Issues, Hears More from Whistleblowers” by Joanne S. Eglovitch.




You may also be interested in our “How to Comply with cGMPs” Primer. 




All pharmaceutical and biologics stakeholders, especially lawyers, should understand the current framework for creating and following good manufacturing practices (cGMPs), and the steep legal and regulatory consequences for failing to meet those standards.  This conference, specifically tailored for lawyers but appropriate for all drugs and biologics stakeholders, provided an overview of cGMPs (including revisions mandated by enactment of Section 711 of FDASIA), how FDA evaluates company compliance with good manufacturing practices (including an examination of recent guidelines published by the International Conference on Harmonization and the latest developments on quality by design), and practical advice for how to remain current and compliant. 


Who Attended

  • Drug stakeholders regulated by FDA
  • Drug manufacturer staff
  • Compliance and regulatory specialists
  • Independent compliance consultants
  • In-house counsel
  • External attorneys
  • Academics


Audience

  • Biologics
  • Drugs