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Declan O’Shea

As seen in: Pharmaceutical Online
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Articles by Declan O’Shea

07.30.24 -- Making Good Decisions When FDA Investigators Come Knocking

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By Declan O’Shea, Dec Group, Jenny Minigh, inSeption Group
| Pharmaceutical Online Verified
Proactive Strategies To Evaluate And Mitigate Supply Risk Explore strategies that can help build an understanding of risk assessment, in addition to how to identify and address a study’s protocol requirements, drug characteristics, packaging specifications, and more. Understanding Biosafety Levels To Ensure Safety Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.
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02.09.24 -- Driving Pharma/Biotech Capacity With Smart Manufacturing

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By Laks Pernenkil, Cheryl Abernathy, Declan O’Shea, Dec Group
| Pharmaceutical Online Verified
It's time for manufacturers to consider a new approach to capacity management, one that can not only resolve today’s challenges but also position the enterprise to drive innovation and resilience in the future. You can leverage a smart manufacturing approach in three vital ways. Media And Feed Development: A Guide To Workflow Optimization Gain insight into each development stage and explore best practices that will help achieve your project goals on time and within budget.
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Integrated Annex 1 Compliance – The Impact On Parenteral Filling, Cleanrooms, And Robotics

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By Declan O’Shea
| Pharmaceutical Online Verified
By Declan O’Shea The recent changes to EU GMP Annex 1 display a more serious approach to the filling of parenteral drug products and the quality assurance expected for those products administered into both human beings and animals. With any change in regulation comes the eventual need for compliance.
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