Safety signals are early signs that a drug, device, or treatment may be causing harm. These signals come from many places, like clinical trials, post-market surveillance, and patient reports. With so much data coming in, it can be hard to know what t
A Step-by-Step Guide to U.S. Regulatory Agencies in Clinical Trials: FDA, HHS and OHRP
Clinical trials play a vital role in testing new drugs, devices, and treatments. These studies help determine if medical innovations are safe and effective. But behind every trial is a network of federal agencies responsible for protecting the public
Asbestos Exposure in the U.S.: Trends, Statistics, and Industry Hotspots
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Legal Penalties for Failing to Train Workers on Asbestos Hazards
Training workers on asbestos safety is not optional—it's the law. Asbestos, once commonly used in construction and manufacturing, is now recognized as a serious health hazard. Without proper training, workers may unknowingly expose themselves to dang
Summer Construction and Asbestos Exposure: Heat Isn’t the Only Hazard
Summer is a busy season for construction. Longer daylight hours, dry weather, and project deadlines often push teams to work faster and harder. But with the rise in heat comes another silent threat, asbestos exposure, especially during demolition or
Staying Safe from Arsenic Exposure: A Role-Based Guide for Industrial Workers
Arsenic is a toxic element found in many industrial processes, from metal smelting and wood treatment to chemical manufacturing and glass production. Long-term exposure, even at low levels can lead to serious health problems such as lung cancer, skin
Practical Tips for Starting a Computerized Systems Validation (CSV) Project
Computerized Systems Validation (CSV) is a critical process in regulated industries like pharmaceuticals, biotech, and medical devices. It confirms that software and digital systems work as intended and meet all compliance requirements, especially th
How to Train Microbiology Lab Staff on cGMP Requirements: A Supervisor’s Guide
Training microbiology lab staff on current Good Manufacturing Practices (cGMP) is one of the most important tasks a supervisor can take on. Clean lab practices, proper documentation, and correct testing techniques are all part of protecting product q
Top cGMP Violations in Analytical Labs: FDA 483 and Warning Letter Trends
Analytical labs play a central role in drug development and manufacturing. Whether testing raw materials, finished products, or environmental samples, the accuracy and integrity of lab data are vital for patient safety and regulatory compliance. That
Is ISO 9001:2015 Legally Required? Understanding Its Role in Regulatory Compliance
ISO 9001:2015 is one of the world’s most recognized quality management standards. It helps organizations build reliable systems, improve consistency, and meet customer expectations. But a common question still comes up: Is ISO 9001 legally required?T