Science and Regulatory Affairs
Management on Outsourced Operations
Group Leaders:
Susan J. Schniepp
Vice President of Quality
Allergy Labs
sschniepp@allergylabs.com
Karen S. Ginsbury
CEO
PCI Pharmaceutical Consulting Israel
kstaylor@netvision.net.il
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.