Insights On Regulatory Compliance
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Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing
3/10/2023
Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.
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Biological Indicators - Identification And Purification
10/7/2022
In this session, an expert walks you through the purity testing process and explains identification methods for biological indicators to help end users.
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Microbial Challenge In-Use Studies
6/13/2024
Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.
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Overcoming Hurdles With A Contamination Control Strategy
7/26/2024
Learn about the importance of a facility-specific CCS, explore common hurdles encountered in its development and get practical advice on creating a robust and compliant strategy.
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EMA Adopts Collaborative Approach With ATMP Guideline Update
7/17/2024
The EMA has taken a collaborative approach with its updated ATMP guideline, aiming to streamline development and clarify regulatory expectations for cell and gene therapies across Europe's landscape.
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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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A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks
6/6/2024
A mobile cleanroom facility was needed for manufacturing a new monoclonal antibody product for phase 1 clinical trials. The facility had to have the ability to be repurposed for additional applications.
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Applying Quality System Regulation (QSR) Best Practices To Improve Regulatory Compliance
9/20/2022
QSR compliance can be complex, but it doesn’t have to be burdensome. Implementing these best practices will improve your regulatory compliance while producing a product ready for market.
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How Crucial Is Culture Media Selection In Environmental Monitoring?
6/20/2023
Explore culture media regulatory requirements, the impact of manufacturing guidelines and media features and specifications on environmental monitoring, and the importance of media supplier selection.
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Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance
6/6/2024
Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.