Compounding Pharmacies and USP <797> Compliance
How contract labs support compounding pharmacies with sterility, potency, and compliance testing under USP <797>
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Legal and Regulatory Articles
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CAPA Systems in GMP Environments: Essential Best Practices
Discover best practices for implementing CAPA systems in GMP labs. Learn how to improve compliance, reduce risks, and streamline quality processes
Tackling FDA Import Detentions with Third-Party Lab Testing
How partnering with accredited contract labs can provide the critical testing and documentation needed to overcome FDA import detentions and get your products to market
FDA Approves ELISA Companion Diagnostic
A comprehensive solution for precise concizumab-mtci monitoring in hemophilia patients
ASK THE LAB EXPERT: Promoting User-First Lab Automation with AI-Powered Innovations
Wael Zebdeh discusses how AI is reshaping laboratories and ensuring “quality, speed, and compliance coexist seamlessly”
Navigating Compliance and Regulatory Standards with LIMS
How modern LIMS streamlines lab compliance with international standards
2025 Laboratory Quality & Compliance Week Webinars Available On Demand Now
Watch your favorite or all the webinars from the virtual event on demand for free
SQF Certification: A Trusted Standard for Farm-to-Fork Food Safety
Whether you're growing produce, packaging frozen meals, or operating a logistics hub, SQF certification offers a pathway to safer products, better operations, and greater market reach.
Laboratory-Developed Tests: Recent Regulatory Changes and Industry Effects
Evolving FDA regulations and legal rulings affecting LDTs have impacted clinical and contract labs—a recent development may change the course
Laboratory Quality & Compliance Week: Simplifying Data Governance
Tracy Hibbs' session covers key elements of data governance, vigilant monitoring, and quality management
Laboratory Quality and Compliance Week: FDA Warning Letter Trends for Testing Labs
Dr Constance Y. Fears, one of the speakers at our upcoming virtual event, discuses her career as a drug investigator and the FDA 483 Warning Letter trends
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