Summary of Breakout Session B: Regulatory Expectations for CGMP

PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):713-4. doi: 10.5731/pdajpst.2011.00847.

Abstract

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA).

MeSH terms

  • Biological Products*
  • Drug Design
  • Humans
  • San Francisco
  • Viruses*

Substances

  • Biological Products