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| Webinar: Cleanroom Conceptual Design Paradigm: Converting Spaces for GMP Operations | This webinar on September 26, 2024, at 11:00am EDT, will explore designing life sciences cleanroom spaces that allow for the development of the science and the capability to host commercial scale GMP manufacturing. Learn more about an integrated design process that gives confidence for regulatory alignment, optimal design functionality, and environmental performance. |
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| Sustained, Controlled Drug Delivery To The Eye | Article | By Harsh Patel, PhD, Cyonna Holmes, PhD, and Brian Wilson, PhD, Celanese, Celanese | Examine how a platform that leverages polymeric implantable drug delivery systems enables improved bioavailability, patient compliance, and mitigation of issues associated with repeated injections. |
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| Re-Engineering A Complex Process For FDA Compliance | Case Study | Jubilant HollisterStier | Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance. |
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| EMPQ And Validation Support Services | Case Study | CAI | A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite. |
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| Preparing The PMS: A Commercial And Regulatory Imperative | Article | Cencora PharmaLex | Learn how proactive engagement with the Product Management Service (PMS) can pave the way for enhanced decision-making, operational agility, and sustained competitiveness in the pharmaceutical industry. |
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A conversation with R. Tod Urquhart and Alessandro Pelizzi | Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers. |
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