Management on Outsourced Operations
Purpose
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.
Scope
- 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.
An active PDA membership is required to join an Interest Group. Not a member? Join today.
Interest Group Leaders
Maria Amaya, Roche
Morten Munk
Fujifilm Diosynth Biotechnologies
Events and Announcements
More information coming soon.