Process Characterization: Ready for the FDA/EU ICH guidelines

There is a common view among biopharmaceutical regulatory agencies that process validation is requirement for all commercial products. These activities are a critical component in protecting patients by minimizing risk and ensuring product quality throughout a product’s life cycle. Manufacturers have a wide variety of options to choose from when constructing a process validation strategy – including the specific process characterization approaches needed to define a well understood and controlled commercial manufacturing process.

Listen to our on-demand webinar, hosted by France Biotech with Thermo Fisher expert Daniel Baskind, to learn more about this important topic.

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