Insights On Regulatory Compliance
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5 Steps To Better Supplier Quality Audits In Drug Manufacturing
3/24/2023
Explore four legitimate reasons to conduct a supplier audit and five steps to achieve a better supplier quality audit.
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Alofisel P3 Cell Therapy Facility
2/21/2024
Despite various issues with a client's CQV project, CAI delivered the project on time and significantly contributed to the delivery of the first ATMP facility in Ireland.
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What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product
8/11/2023
Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.
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Pharmaceutical Quality Management Trends: Adopting Intelligent Solutions
3/10/2023
Learn how to optimize pharma quality management data and design, themes to keep in mind when implementing AI, and ways to lay the foundation for AI solutions.
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Partnering On An Innovative Hydrogel-Based Treatment For Glioblastoma
3/22/2023
Treatments for glioblastoma multiforme (GBM) are in high demand. Learn more about the new possibilities for increased dosing and diffusion capabilities offered by nanoformed APIs.
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Extractables And Leachables: Risk Management And Analytical Solutions
10/11/2023
Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.
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Annex 1 Compliance Guidelines For Biological Indicator Users
6/26/2023
Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators.
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Vigilance Guidance Provides Greater Clarity On MDR Requirements
6/12/2024
Explore how new vigilance guidance under MDR clarifies reporting obligations for high-risk medical devices, ensuring enhanced safety oversight and compliance amid stricter regulations.
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Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials
5/12/2023
Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.
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Using Robotics In The ATMP Space
7/18/2023
With regulatory requirements and GMP recommendations trending towards less human interaction and more robotic automation, robotics is the way of the future for the ATMP industry.