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A material transfer agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the rights and obligations of the recipient with respect to the materials and any progeny ...
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
Technology transfer (TT), also called transfer of technology (TOT), is the process of transferring (disseminating) technology from the person or organization that owns or holds it to another person or organization, in an attempt to transform inventions and scientific outcomes into new products and services that benefit society.
ISO/TR 22411:2008 Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities; ISO 22412:2017 Particle size analysis - Dynamic light scattering (DLS) ISO 22413:2010 Transfer sets for pharmaceutical preparations – Requirements and test methods
The NIH Office of Technology Transfer manages all intramural inventions from the NIH and FDA as mandated by the Federal Technology Transfer Act [4] and related legislation. It was established in 1986 subsequent to the Federal Technology Transfer Act as a centralized group to oversee patent and license matters for all of the NIH Institutes and ...
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
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Biosense Inc.: A company that developed a 3-D cardiac mapping and navigation technology. FineTech: offering sophisticated chemical products and services to the pharmaceutical industry. Regents Biomaterials Ltd: a medical material development company involved in the cartilage repair market.