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Technology transfer is crucial to conveying information and knowledge between independent sites at a single company or between different workplaces. Transferring technology is frequently necessary for process development, manufacturing, and analytical testing. Transfer of scientific and process information is necessary since sites used for development may not be able to support full manufacturing or testing in a GMP environment. Technology used at one site during early development often needs to be transferred to secondary sites or to a separate company or business unit. Process development may involve innovative techniques or quick changes to methods and processes done on a small scale. The information on the final process, including specific details for scale-up requires careful implementation to maintain quality and consistency. Manufacturing and analytical testing are frequently not developed at sites that will perform those services. Initial processes and test methods may change during the final stages prior to technology transfer. Assuring that the process is clearly understood and appropriately run requires excellent tools in technology transfer. When information is not clearly presented the process may not follow all steps as required with the possible result of system or product failures. Identifying and understanding the key issues and pitfalls prior to initiating technology transfer can lead to successful implementation of a process or test method between different sites.
Attendees will receive knowledge on important topics related to technology transfer. Steps necessary to assess processes that need to be in place for a successful technology transfer will be addressed. Written procedures, including manufacturing details and test methods, that are crucial for successful transfers are topics that will be covered during the webinar. The webinar will also discuss possible issues that can arise during transfer that can lead to failure of subsequent procedures or test methods. Steps will be discussed to guide the transfer toward success including samples that should be used and training of those involved in the transfer at all sites. Training of individuals involved in the transfer is a critical area that should be carefully considered. The webinar will also discuss SOPs necessary for technology transfer and documentation of training of scientists and other individuals involved in technology transfer.
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.