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An FDA warning letter is an official message from the United States Food and ... After the FDA completes an evaluation of corrective actions via a follow-up ...
Corrective and preventive action ( CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others ...
US FDA classifies corrections to instructions for Abiomed's blood pumps as most serious. (Reuters) - The U.S. health regulator on Thursday classified corrections made to the instructions for the ...
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 ยง374) "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.
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered ...
A corrective lens is a transmissive optical device that is worn on the eye to improve visual perception. The most common use is to treat refractive errors : myopia , hypermetropia , astigmatism , and presbyopia .
The main difference between the two is that validation is focused on ensuring that the device meets the needs and requirements of its intended users and the intended use environment, whereas verification is focused on ensuring that the device meets its specified design requirements. For instance, a regulatory agency (such as CE or FDA) may ...