A Code of Conduct isn’t just a list of company values or good behavior tips. In many organizations, it plays a key role in holding employees accountable, and in some cases, it may carry legal weight. But when is a Code of Conduct actually enforceable
Who Is Legally Accountable in a Change Control Failure? Quality, Operations, or Management?
In pharmaceutical and biotech manufacturing, changes to processes, equipment, or materials must be handled carefully. That’s why change control is a critical part of any company’s current Good Manufacturing Practice (cGMP) system. But when change con
FDA Regulation of Biotechnology-Derived Products: What You Must Know to Stay Compliant
Biotechnology-derived products (BDPs), such as monoclonal antibodies, gene therapies, and recombinant proteins, are a growing part of modern medicine. These products hold great promise for treating diseases, but they also come with strict regulatory
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
Cleanroom Compliance Under FDA and EU GMP Regulations: What the Law Requires
Cleanrooms are critical spaces in pharmaceutical and biotech manufacturing. These controlled environments are used to produce sterile products and must meet strict standards. Both the U.S. Food and Drug Administration (FDA) and the European Union (EU
FMCSA Regulations on Rear-End Collisions: What Large Vehicle Operators Must Know
Rear-end collisions are among the most common road accidents in the United States. For operators of large commercial vehicles, such as trucks and buses, the consequences can be severe, both in terms of safety and legal responsibility. The Federal Mot
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
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
OSHA Requirements for Construction Safety Orientation: What the Law Demands
Construction work is one of the most dangerous jobs in the U.S. From working at heights to handling heavy machinery, the risks are real and often life-threatening. That’s why OSHA (Occupational Safety and Health Administration) has strict rules in pl
How Long Must Employers Keep Medical and Exposure Records? A Legal Overview
When it comes to workplace safety and health, proper recordkeeping is not just good practice, it’s the law. Employers are required to keep certain medical and exposure records for their workers. These records are important for tracking long-term heal