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Best Practices In Ensuring Quality Standards When Outsourcing to Contract Manufacturers, Licensees and Consultants

Presented at: the Strategic Institute’s Quality & Regulatory Strategies Summit, Toronto, ON, Canada, March 5, 2009

The presentation examines the qualification of a contractor and the responsibilities of contract givers and contractors of all types in compliance with quality standards and GxP practices. Emphasis is placed upon adequate definition of these in the contract, especially the use of the Quality Agreement. Following the creation of the agreement, the operations should be monitored by the sponsor’s staff or a suitably qualified consultant. Exhaustive documentation is essential to the success of the contract.