Leachable risk management continues to be of regulatory interest. However, we continue to rely on experimental extractable studies as predictors of leachable risk. These are complex to design and implement and do not always offer the answer to what is the leachable risk for a drug product or medical device.
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The goal of medical education is to produce a physician workforce capable of delivering high-quality care to our patients and communities.
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Artificial intelligence (AI) - “getting computers to do things that normally require a human mind” - is routinely being put to good use when making pharma clinical development decisions.
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ON24
Historically, distillation has been the most common technology used to produce Water for Injection (WFI), due to prior process advantages and historical regulatory requirements. Changes in the European Pharmacopeiano longer require the use of distillation systems to produce WFI. In this webcast, learn about the impact of this regulatory change on water system design and how reverse osmosis and ultrafiltration can be used to produce WFI with significant lifecycle cost advantages.
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