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By Hemadri Doma, Tolmar Inc. | In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. Review the key elements of the guidance. |
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| Integrating Early Development With Clinical Supply | Webinar | Catalent | In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes. |
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| What Is An Aqueous Cleaner? | Article | By Michael Moussourakis, Jeff Phillips, Stacy Silverstein, and Malcolm McLaughlin, Alconox Inc. | This chapter of The Aqueous Cleaning Handbook explains what an aqueous cleaner is, what it contains, and how it can improve your cleaning process. |
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