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Form FDA 483. The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". [1] Form FDA 483, [2] "Inspectional Observations", is a form used by the FDA to document and communicate concerns discovered during these inspections.
Observation in the natural sciences [1] is an act or instance of noticing or perceiving [2] and the acquisition of information from a primary source. In living beings, observation employs the senses. In science, observation can also involve the perception and recording of data via the use of scientific instruments.
The no-observed-adverse-effect level (NOAEL) denotes the level of exposure of an organism, found by experiment or observation, at which there is no biologically or statistically significant increase in the frequency or severity of any adverse effects of the tested protocol. In drug development, the NOAEL of a new drug is assessed in laboratory ...
Behavior-based safety (BBS) is the "application of science of behavior change to real world safety problems". [1] or "A process that creates a safety partnership between management and employees that continually focuses people's attentions and actions on theirs, and others, daily safety behavior." [2] BBS "focuses on what people do, analyzes ...
He was born on October 6, 1886, in Bennington, Vermont. He was an assistant superintendent of the Engineering and Inspection Division of Travelers Insurance Company when he published his book Industrial Accident Prevention, A Scientific Approach in 1931. [1][2] One empirical finding from his 1931 book became known as Heinrich's law: that in a ...
Postmarketing surveillance. Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis ...