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Course offering number:1506-106

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Outsourcing Pharmaceutical Operations
June 1-2, 2015
New Brunswick, NJ

Who Should Attend
This course has been designed for those who need to implement, improve, and/or manage outsourced operations in the pharmaceutical industry as well as the biological, device, diagnostics and cosmetics industries. It will be of particular interest to individuals in:

  • Corporate & Plant Management
  • Purchasing: Materials Management/Project Management
  • Manufacturing
  • Packaging
  • Engineering
  • Process Development
  • Regulatory Affairs
  • QA/QC
  • Management of Contract Manufacturing Organizations

RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

Outsourcing has become a critical segment of every pharmaceutical company’s operational strategy, yet few clients or contractors achieve the envisioned expectations of these important partnerships. The course examines the root causes of these issues which are much broader and deeper than the technical capability to perform a process.

This practical course outlines both the strategic and tactical outsourcing processes of selecting, monitoring, and managing an outsourced operation. It includes a review of domestic and international regulatory requirements and operational aspects including the role of the quality system. An in-depth discussion of risk-based supplier and material qualification processes, supplier selection, supplier monitoring, contracts/agreements, and auditing will be presented.

In addition, the course examines how best practices of project management can transform an outsourcing schedule into a true project plan.

The course includes hands-on workshops in which mini-teams analyze case studies and present their findings.

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