Insights On Regulatory Compliance
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5 Signs You've Outgrown Your Quality Management System (QMS)
12/27/2024
An outdated QMS limits growth. Explore how upgrading to an advanced, configurable system like MasterControl can ensure scalability, automation and innovation.
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N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit
6/30/2025
Discover a company that tripled productivity and cut costs by optimizing its seed train process to achieve major gains without infrastructure expansion.
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AI Implementation To Enhance Quality
2/11/2025
Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.
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Implementing A Risk-Based Approach To Calibration
2/20/2024
Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.
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Challenges In Developing Medical Devices From Animal-Based Biomaterials In China
11/11/2024
Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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Navigating Regulatory Compliance: A Success Story In The Pharma Industry
4/10/2025
Reveal how one pharmaceutical facility overcame strict cross-contamination rules and space limits without costly building modifications to ensure operational continuity.
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Essential Insights Into Pharmaceutical Product Release: Part 2
1/13/2025
Optimizing pharmaceutical product release requires effective planning, specification development, electronic systems, and collaboration with CMOs, ensuring compliance, efficiency, and quality in the drug manufacturing process.
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Key Takeaways From The ISPE Ireland Annex 1 Event
4/12/2024
Key insights from the ISPE Ireland Annex 1 Event shed light on challenges and solutions in meeting EU GMP guidelines for sterile medicinal products.
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Tips For Viral Vector Production
4/16/2024
Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
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Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?
9/5/2023
Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.