Education Sessions

Outsourcing: Friend or Foe? (303)

28 October 08.15-11.30 Track: Manufacturing Operations

ISPE CEUs: 0.2

agenda(PDF Current as of 4 September 2008)

Increased outsourcing to Contract Manufacturing Organizations (CMOs) for the manufacture of pharmaceuticals is raising very important questions for both the contractor and the pharmaceutical company.

  • Are CMOs aware of regulatory and client audit requirements, particularly for high hazard compounds?
  • From the CMOs’ perspective, what do they need to offer in order to meet the expectations of the pharma company and to be the best that they can be?
  • What are the issues at an operational level?
  • Is the CMO route here to stay or is it about to change again?
  • What new challenges are emerging in this increasingly popular manufacturing setting?

Gain insight on these questions and join in interactive discussion among speakers and delegates to understand both the issues above and others that will emerge from discussion. ISPE offers these special sessions as opportunities to create the common ground, which is vital for moving the industry ahead as it faces and articulates challenges in an open setting.

How You Will Benefit

At the end of this session, participants will be able to:

  • Articulate contracting company goals and expectations when working with CMOs and vice versa
  • Identify challenges that are currently arising in pharma/CMO projects
  • Describe good practices and potential solutions to problems that other companies have experienced
  • Outline new challenges that may be on the horizon with insight from the perspective of the CMO if pharma, and pharma if CMO

Who Should Attend

Management, operations, outsource procurers, CMOs, quality, regulatory and environmental health and safety professionals

ISPE Communities of Practice (COPs)

Containment and Sterile Products Processing (SPP)

 

 

Session Leader

Session Speakers

 

Annual Meeting Sponsors