Institutional Review Boards (IRBs) play a key role in research oversight. Their job goes far beyond reviewing study designs and consent forms. IRB members are responsible for protecting the rights, safety, and well-being of human subjects. But anothe
Quick Tips for Complying with In Vivo Bioequivalence Program Requirements
Conducting in vivo bioequivalence (BE) studies is a critical step for companies developing generic drugs. These studies compare a test product to a reference drug to show that both perform the same in the human body. The U.S. Food and Drug Administra
How to Prepare for an FDA BIMO Inspection: A Clinical Investigator’s Compliance Guide
When the FDA notifies you of a Bioresearch Monitoring (BIMO) inspection, it can feel overwhelming at first. These inspections are designed to review the quality and integrity of the clinical trial data submitted to the agency and to check whether inv
Engineering Controls for Benzene Exposure: What the Data Says About Their Effectiveness
Got it! From now on, I’ll bold all statistical data in your articles as per your preference. Let me now continue and complete the article with that in mind:Engineering Controls for Benzene Exposure: What the Data Says About Their EffectivenessBenzene
OSHA Requirements for Bench and Pedestal Grinders: What the Law Demands
and pedestal grinders are common tools in many workshops and maintenance areas. These machines bring high-speed rotating wheels that can cause serious injuries if not used properly. The Occupational Safety and Health Administration (OSHA) sets clear
Battery and Charger Safety During Holiday Downtime: Prevent Fires and Leaks
Holiday season means winding down operations, but batteries and chargers still require attention—even when staff are away or shifts are reduced. Whether your facility uses forklifts, backup power systems, or everyday electronics, risks don’t pause ju
Documentation Safety: Why Accurate Batch Records Protect More Than Just Compliance
Every batch of pharmaceutical product starts with documentation. From raw material receipts to production logs, each step in manufacturing is recorded in batch records. On paper, this may look like a mundane task. In reality, those pages are vital to
What You Can (and Can’t) Give Healthcare Professionals Under PhRMA
Pharmaceutical companies often interact with healthcare professionals to share information about drugs, but ethical rules prevent giving inappropriate gifts or awards. The Pharmaceutical Research and Manufacturers of America (PhRMA) has set a clear c
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