INSIGHTS ON REGULATORY COMPLIANCE
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![Compliance GettyImages-1212446127]( "Understanding ISO/TR 14644-21 Airborne Particle Sampling Techniques")
Understanding ISO/TR 14644-21 Airborne Particle Sampling TechniquesIndustry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.
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![Documentation]( "Why You Need A Document Management System In Life Sciences")
Why You Need A Document Management System In Life SciencesIn this blog we highlight the history and purpose of a document management system and look into the future with cloud-based electronic document software.
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![GettyImages-1297393276 Scientist using computer in lab]( "Modernizing Compendial SEC Methods For Biotherapeutics")
Modernizing Compendial SEC Methods For BiotherapeuticsExplore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.
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![Lab Production Line GettyImages-1344271715]( "How To Improve CAPA Metrics")
How To Improve CAPA MetricsA CAPA management system can provide your company with the ability to recognize and correct risks. Learn how to ensure your CAPA management system benefits the manufacturing process.
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The Write Side Of AI: Helping Hands, Not Replacement Plans3/1/2024
AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.
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The Container Closure Integrity Requirements In The Revised EU Annex 111/21/2022
Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.
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Extractables And Leachables Testing4/9/2024
Learn how to navigate the extractables and leachables regulatory landscape and implement best practices for leachables analysis in your pharmaceutical development process.
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Are Electronic Manufacturing Logbooks Better Than Paper?4/10/2023
We accept the aid of automated paperless technology in our everyday lives, so why not in life sciences manufacturing? Check out some of the benefits of eLogbook management.
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Expert Approaches To Pharmaceutical Containment Design And Facility Integration4/18/2023
Review the process requirements, workflows, and process interventions that are key to your containment isolators achieving compliance with both cGMP and BSL-3.
REGULATORY COMPLIANCE SOLUTIONS
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![iStock-941351188-lab-cleanroom-sterile]( "Out Of Specification (OOS) Software For Life Sciences")
The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.
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![GettyImages-1306664598 lab research]( "Psychedelics: Drug Development Capabilities")
Learn how harnessing a CDMO’s extensive knowledge and skills in dealing with controlled substances can help you advance your innovative psychedelic therapeutic safely and efficiently.
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![Cell Therapy]( "Cleanrooms And Equipment For Cell Therapy Drug Manufacturing")
Delivering on the promise of cell and gene therapy through Germfree products and services.
Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.
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![File Sync Solutions]( "Electronic Batch Records")
Ensure compliance and improve efficiency by automating your paper-based systems.
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![Safety & Pharmacovigilance Solutions]( "Pharmacovigilance")
We support our corporate sponsors by providing both assessment and processing of SUSARS as per local and country requirements. We provide reliable reporting of adverse events, unbiased signal detection, and potential mitigation and risk management plans, based on any findings as requested.
