Evaluating Quality Systems With Your Manufacturing Partners
Source: Aldevron
The landscape surrounding regulatory guidance is constantly changing as the cell and gene therapy industry continues to evolve. Cell and gene therapy sponsor companies need to know how to evaluate a new manufacturer's quality system, and how to verify that it complies with global regulatory bodies' prescribed guidance.
Ken Bonnell, Senior Vice President of Quality and Regulatory Affairs, Aldevron, shares insight on what to look for and what is important when evaluating quality systems with manufacturing partners.
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