Regulation
Everyone
- 7 videos | 42m 13s
Learn about biomanufacturing regulation.
WHAT YOU WILL LEARN
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Understand the basics of regulationUnderstand process control, validation and product testingUnderstand quality by designUnderstand manufacturing process variants
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Understand more about manufacturing process variantsUnderstand the industry from an expert perspectiveUnderstand the industry from an expert perspective
IN THIS COURSE
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7m 32sIn the following lecture, Dr. Stacy Springs looks at the beginnings of regulation in the United States in more detail. FREE ACCESS
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5m 52sIn the lecture that follows, Dr. Stacy Springs will introduce you to the concepts of process control, process validation, and product testing, as well as tell you about the three stages to process validation. FREE ACCESS
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4m 57sIn this video segment, Dr. Stacy Springs describes in more detail each element of QbD and its importance in biomanufacturing. FREE ACCESS
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6m 11sIn the following lecture, Dr. Springs walks you through several examples to explain the difference between product-related impurities and product-related substances. FREE ACCESS
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5m 56sIn this final segment on regulatory processes, Dr. Springs examines how manufacturing process changes can cause changes to the end product and how this can impact a manufacturer's ability to license the product. FREE ACCESS
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6m 21sLearn more about the industry from an expert perspective FREE ACCESS
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5m 27sLearn more about the industry from an expert perspective FREE ACCESS
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