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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 systems ...
FDA warning letter. (Redirected from FDA Warning Letter) An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as:
Good documentation practice. 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 ...
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its ...
US FDA classifies corrections to instructions for Abiomed's blood pumps as most serious. March 21, 2024 at 3:47 PM. (Reuters) - The U.S. health regulator on Thursday classified corrections...
Laser-Assisted in Situ Keratomileusis (LASIK), commonly referred to as laser eye surgery or laser vision correction, is a type of refractive surgery for the correction of myopia, hyperopia, and an actual cure for astigmatism, since it is in the cornea.
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).
Validation and verification are procedures that ensure that medical devices fulfil their intended purpose. Validation or verification is generally needed when a health facility acquires a new device to perform medical tests.
Protein digestibility-corrected amino acid score ( PDCAAS) is a method of evaluating the quality of a protein based on both the amino acid requirements of humans and their ability to digest it. The PDCAAS rating was adopted by the US FDA and the Food and Agriculture Organization of the United Nations / World Health Organization (FAO/WHO) in ...
Process Validation. Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [1]