INSIGHTS ON REGULATORY COMPLIANCE
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![Ecolab - 483 observations]( "Observations That Can Be Avoided With The Right Software Partner")
Observations That Can Be Avoided With The Right Software PartnerFDA 483 findings frequently cite a lack of data integrity, process adherence, and quality control. Find out why these issues persist and the significant risks they pose to pharmaceutical manufacturers today.
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![GettyImages-1087218908 In the Manufacturing Facility Team of Scientists Wearing Sterile Protective Coverall]( "5 Biggest Sterilization Challenges Facing Manufacturers")
5 Biggest Sterilization Challenges Facing ManufacturersSterility is non-negotiable in pharmaceutical and medical device manufacturing. Discover the top five sterilization challenges facing manufacturers today and the proven strategies to overcome them while ensuring compliance and safety.
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![Panel-2 feature image]( "Navigating The Digital Frontier")
Navigating The Digital FrontierThis panel discussion looks ahead at decentralized manufacturing, key regulatory considerations, and the anticipated future where cybersecurity becomes a paramount focus.
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![GettyImages-2167387195-computer-graphs-hand-team-digital]( "Navigating Technology Transfer In Manufacturing")
Navigating Technology Transfer In ManufacturingTechnology transfer is essential for scaling life sciences innovation. Learn how teams navigate its complexity, overcome common challenges, and leverage digital tools to improve quality.
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Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements6/19/2024
Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.
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N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit6/30/2025
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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Compliance: Framing Success Utilizing PIC/S And EU GMP12/20/2023
Explore the differences between the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide and the EU GMP Guides, and gain insight into the teamwork between the FDA, MHRA, and PIC/S.
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The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly3/3/2025
In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.
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Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations Part 26/16/2025
Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.
REGULATORY COMPLIANCE SOLUTIONS
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![GettyImages-2194013442-laboratory-scientists-computer-evaluating]( "Composable MES For Pharma")
The Composable MES for Pharmaceuticals provides a starting point for you to implement a tailored, connected production system with end-to-end traceability and right-the-first-time electronic batch records (eBR).
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![DD 1 - GCAPP_Valor size 2 Vial]( "The Future Of Glass Packaging Is Here")
Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.
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![Minimate™ EVO]( "Precision Filtration With Unmatched Control And Seamless Validation")
Experience reliable, user-friendly buffer exchange and sample concentration with a system enhanced with precise pressure control, improved stirring, and durable components for effortless lab-scale filtration.
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![molecular-devices-clonepix2-mammalian-colony-picker]( "Transformative Cell Line Development Workflow ClonePix 2 Mammalian Colony Picker")
A transformative cell line development workflow with automated clone screening and optional monoclonality assurance on day 0*
The ClonePix® 2 Mammalian Colony Picker is a complete solution for the automated screening and objective selection of high-value clones across diverse cell types.
The ClonePix® 2 Mammalian Colony Picker is a fully automated system for selecting high-value clones used in antibody discovery and cell line development. Screen more clones in less time with monoclonal verification on day zero, then screen and identify for highest producers in weeks, not months.
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![GettyImages-1483243079-doctors-data-computer-analysis-tablet-office]( "Combat Nitrosamine Challenges With Comprehensive Analytical Solutions")
As consumer safety becomes increasingly vital, the analysis of nitrosamine impurities in pharmaceuticals is critical. Classified as probable human carcinogens, nitrosamines pose significant health risks, prompting regulatory bodies like the U.S. Food and Drug Administration (FDA), Health Cananda and the European Food Safety Authority (EFSA) to implement strict guidelines.
