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R&D Quality as the Foundation for Product Quality, Upcoming Webinar Hosted by Xtalks

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Xtalks Life Science Webinars

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.


TORONTO (PRWEB)

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.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks, visit http://xtalks.com.

For information about hosting a webinar, visit http://xtalks.com/why-host-a-webinar/.

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