In this free webinar, the featured speaker will discuss the role of R&D in the Regulatory Roadmap for the Product Lifecycle and the activities that contribute to the quality of material produced in R&D. He will also address quality activities for different stages of R&D and the role of GLP testing in late stage R&D.
TORONTO (PRWEB) May 14, 2020
This webinar will focus on current practices in use at Cytovance Biologics as part of product lifecycle management. At times, projects are received with differing amounts of background information and this webinar will discuss control of quality during the various stages of R&D while still maintaining the flexibility necessary for research. There must be dynamic balancing of expectations for quality with the needs of the scientists to understand and characterize the material being produced particularly in R&D.
Even early-stage R&D benefits from a quality mindset and the speaker will discuss ways that the R&D Quality Group supports the programs. Flexibility is key at this stage and R&D quality activities evolve to focus on the needs of the scientists to collect valid data. As the processes and procedures become better established, the amount and types of documentation increase.
R&D Quality activities in the latter phases of research and development are controlled to allow the ultimate assembly of a documentation package to support the clients’ submissions to regulatory bodies. Documentation at this point includes both written procedures used by R&D to produce the material and method transfer reports that support the eventual authoring of scaled up current Good Manufacturing Practice (cGMP) batch records.
The FDA expects that the drug substance used for toxicology and other testing will be representative of the material eventually produced in cGMP Manufacturing. R&D Quality is part of the team reviewing documentation of production and testing. In many cases, clients request GLP testing of the Tox material. Good Laboratory Practices (GLP) testing is a formal prospective test plan administered by R&D Quality and performed by R&D scientists.
Join Gregory Svanas, Director of Research and Development Quality, Cytovance Biologics in a live webinar on Monday, June 1, 2020 at 12pm EDT (5pm BST/UK).
For more information or to register for this event, visit R&D Quality as the Foundation for Product Quality.
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