A practical guide to understanding how FDA inspections enforce postmarketing reporting rules and protect public health. Table of Contents Introduction Understanding Postmarketing Adverse Drug Experience Reporting FDA’s Autho
Safe Handling Practices During Product Destruction in Regulated Industries (USA)
In regulated industries, like pharmaceuticals, biotech, chemicals, and food, product destruction is a serious task. Whether the product is expired, recalled, contaminated, or simply unsellable, it must be destroyed properly. This keeps workers safe,
Courtroom Conduct and Credibility: What the Data Says About Witness Impact in Regulatory Trials
Witnesses play a powerful role in shaping the outcome of regulatory trials and courtroom decisions. But their influence isn’t based on just facts, it's also about how they act, speak, and are perceived. Recent research highlights how confidence, body
How FDA Inspects Computerized Systems Under cGMP: A Legal Overview
Computerized systems play a key role in today’s pharmaceutical and biotech industries. From data recording to equipment control, they help maintain quality and consistency. But with more use of digital systems comes closer inspection by the U.S. Food
Heatwaves and Server Room Safety: Environmental Controls to Protect Computerized Systems
Extreme heat can damage more than just outdoor equipment. When a heatwave hits, even indoor areas like server rooms can suffer. For companies relying on validated systems and digital documentation, the impact can be serious. Systems can slow down, ov
How to Identify and Correct Common Food Safety Violations: A Step-by-Step Guide for Inspectors
Food safety inspections play a key role in protecting public health. When violations are spotted and fixed, foodborne illness risks go down for everyone. This guide helps health inspectors spot and fix four major issues: employee hygiene, equipment s
How Well Are Food Establishments Preparing for Inspections? A Look at Pre-Inspection Readiness Trends
Food safety is a top priority for public health, and inspections play a vital role in keeping restaurants, processing plants, and retail vendors safe. In recent years, data shows that most food establishments are well-prepared before their inspection