Management on Outsourced Operations


Mission Statement

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. 


  • 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.
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Interest Group Leaders
Maria Amaya, Roche
Morten Munk
Fujifilm Diosynth Biotechnologies
Events and Announcements

More information coming soon.