Management on Outsourced Operations

Group Leaders:

Susan J. Schniepp
Vice President of Quality
Allergy Labs

Karen S. Ginsbury
PCI Pharmaceutical Consulting Israel

Mission:  The Management on Outsourced Operations Interest Group will provide a platform for sharing information among PDA members on management, oversight and regulatory responsibilities of outsourced activities, and, serve as the liaison between RAQAB and follow-up of the PCMO Task Force. 

Scope of the Interest Group:

  • To monitor regulatory developments, guidances and standpoints regarding management of outsourced activities
  • To support the preparation of position papers, Points to Consider documents, or a Technical Report on outsourcing as well as submission of articles to the PDA Letter; which may evolve from IG Meetings
  • To proactively identify ways of ensuring a global approach for integration of ICH Q10 using ICH Q9, and principles of Quality Risk Management in managing outsourced activities
  • To provide input to scheduling and content of PDA conferences and TRI courses on outsourcing.