Controlling Outsourcing Using Quality Principles - For Lifesciences Companies (FDA Compliance Train)
Venue: Online Event
|Event Date/Time: May 20, 2011||End Date/Time: May 20, 2011|
The FDA has begun to more closely scrutinize the control of outsourcing for biologicals, pharmaceuticals, and medical devices. In the Quality Systems Approach to Pharmaceutical GMP, the FDA defines outsourcing as involving hiring a second party under a contract to perform the operational processes that are part of a manufacturerâ€™s inherent responsibilities. The International Conference on Harmonization (ICH), and the Global Harmonization Task Force (GHTF) standards also include requirements for outsourcing. The qualification of contractors for outsourcing is much more comprehensive than that required for suppliers. The same principles apply to all medical products.
Many virtual companies tend to shift responsibility from themselves to the contractor for compliance to regulatory requirements. They are often too willing to relinquish the required control over their valuable income producing assets to outsiders.
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