Insights On Quality Assurance
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The Problems With Construction Quality In Life Sciences
11/7/2023
In the mission-critical construction industry, quality management is underperforming. Understand the importance of quality control in life sciences commissioning processes and construction programs.
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A Guide To Writing Effective SOPs In Life Sciences
8/17/2022
We share some SOP guidelines that can help you build and manage documents that are easily accessible, relevant, and something your team can consistently rely upon.
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A Risk-Based Approach To Quality Processes In Life Sciences
10/4/2022
Learn how to embed risk-based thinking into quality efforts with an integrated risk management software.
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Achieving Next-Level Quality With Digital Technology In Manufacturing
9/30/2022
Learn how a modern Manufacturing Execution System (MES) is using digital production records to help manufacturers regulated by the FDA improve their quality and efficiency goals.
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A Roadmap For Implementing Analytical QbD
7/5/2024
Discover how and analytical QbD approach ensures that analytical methods are not only effective but resilient to variations, ultimately enhancing the reliability and accuracy of the data generated.
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Round 2: Mastering NDA Submission And A Resubmission Rescue Mission
3/2/2023
This biopharmaceutical company had to overcome trial master file (TMF) transfer from a previous licensee, staff turnover, and then a resubmission of its NDA.
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Bioproduction Analytics To Support Optimized Media Development
9/12/2023
Designing and optimizing a cell culture medium can be a complex and time-consuming process, and accurate analytics are vital in streamlining media development to achieve long-term success.
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Nitrosamine Impurities Deadline: Are Your Products Compliant?
11/6/2023
The FDA nitrosamine contamination guidance set deadlines of Nov. 1, 2023, for risk assessment updates and Aug. 1, 2025, for full NDSRI limit compliance.
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Cell Therapy Process Development Made Easy
3/27/2024
Explore how Fast Trak™ process development services offered by Cytiva can guide you through achieving GMP compliance in your cell therapy manufacturing process.
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Streamline Early-Stage Development To Reach The Clinic Faster
7/17/2023
Early-stage development is an iterative process, continuously generating new data and insights to optimize the product based on emerging knowledge.