2014 Process Development Symposium
Technology Transfer Documentation the Key to Success.
Author
Successful commercialization of new products is the life blood of business. Many industries institutionalize the preparation of Technology Transfer Documents. This is specifically true for Industries such as the Pharmaceutical, Flavor & Fragrance, and Medical Devices etc. which comply with Good Manufacturing Practice (GMP), and/or International Committee for Harmonization (ICH) regulations. For many businesses, including Small Business, Technology Transfer (TT) Documents are considered “Best Practice”. Technology Transfer documents are the common thread in each of these Industries or businesses. In all cases the overall success of the business is tied to the use and quality of the Chemical and Engineering information needed by the stake-holders. It is up to an organization’s leaders to create a culture that fosters collaboration. It is these soft skills coupled with organizational leadership that create successful TT, successful products and successful businesses. For companies that depend upon the use of contract development and manufacturing services, the organizational issues and collaboration become even more challenging. This presentation will discuss the TT content and the soft skills needed to produce quality TT Documents. “Best Practice” requires company collaboration to ensure that the stake-holders’ needs are met and foster company success.