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.
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Legal and Regulatory Articles
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:Â 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
What is ISO 9000?: A Comprehensive Guide to Quality Management Systems
ISO 9000 lays down the fundamental concepts and terminology used in the family of quality management standards
Laboratory Developed Tests (LDTs): An In-Depth Overview
The regulatory future of LDTs is evolving rapidly and the best way forward is to remain keyed-in
ANSI and NIST Extend Memorandum of Understanding
The Memorandum of Understanding to support continued collaboration in standardization, has been extended by ANSI and NIST
Preformed Thermoplastic Pavement Marking Materials’ Standard
Applications include pavement marking directional symbols, pedestrian crossings, and parking emblems
Supporting Lead Paint Analysis with Proposed ASTM Standard
ASTM’s paint committee is developing a standard for rapid analysis of new paint samples for the determination of lead content
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