If you manufacture medical devices, you must follow strict rules for handling complaints. These rules are explained in 21 CFR Part 820.198, which is part of the FDA’s Quality System Regulation (QSR). Failing to meet these requirements can result in s
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
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
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 Grinder Safety - Bench & Pedestal Introduction Bench and pedestal grinders are common tools in many workshops and maintenance a
Cleanroom Compliance: FDA 21 CFR Part 211 & EU GMP Annex 1 Cleanrooms are critical spaces in pharmaceutical and biotech manufacturing. These controlled environments are used
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
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
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
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