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complaint definition fda

quality complaint definition, quality complaint meaning | English dictionary English-French English Synonyms English for learners Grammar Search also in: Web News Encyclopedia Images Search Synonyms Conjugate Speak Suggest new translation/definition quality   
      n    pl    , -ties    1    a distinguishing characteristic, property, or attribute   
2    the basic character or nature of something   
3    a trait or feature of personality   
4    degree or standard of excellence, esp. a high standard   
5    (formerly) high social status or the distinction associated with it   
6    musical tone colour; timbre   
7       (Logic)    the characteristic of a proposition that is dependent on whether it is affirmative or negative   
8       (Phonetics)    the distinctive character of a vowel, determined by the configuration of the mouth, tongue, etc., when it is articulated and distinguished from the pitch and stress with which it is uttered   
9    modifier    having or showing excellence or superiority   
a quality product      
      (C13: from Old French qualité, from Latin qualitas state, nature, from qualis of what sort)   

draft-quality printing   
      n       (Computing)    low-quality, high-speed output in printed form from a printer linked to a word processor   
   Compare       →    letter-quality printing    letter-quality printing   
      n       (Computing)    high-quality output in printed form from a printer linked to a word processor   
   Compare       →    draft-quality printing    quality control   
      n    control of the relative quality of a manufactured product, usually by statistical sampling techniques   
quality factor   
      n    a property of ionizing radiations that affects their complaint-definition-fda-rid-0.html. complaint letter examplesability to cause biological effects. For weakly ionizing radiations such as gamma rays it has value 1 whilst for alpha rays it is about 20 ,    (Former name)    relative biological effectiveness    total quality management   
      n    an approach to the management of an organization that integrates the needs of customers with a deep understanding of the technical details, costs, and human-resource relationships of the organization ,    (Abbrev.)    TQM    English Collins Dictionary - English Definition & Thesaurus    See also: quality control, quality factor, total quality management, qualify

Collaborative Dictionary     English Definition adequate adj. suitable in quantity or quality janky adj. of extremely poor or unreliable quality ; very low-end [US];[informal] I shouldn’t have bought that used car, it’s way too janky. / There's hardly anywhere to eat other than a janky food place. Also: jank make a silk purse out of a sow's ear exp. the impossibility to make a good quality product using bad quality materials cyber protest n. cyber protest is expression of complaint through the medium of electronic communication on the electronic and digital Medias. [Tech.];[Leg.] vain adj. the quality of something that fails to achieve what was intended; useless craption n. word created with "crap" and "caption" to mean a bad quality caption [Fam.];[Fig.] guy time n. When men have quality time together, and do "guy" things. [Slang] related to bro-mance bag of wank n. something not worthy; something of poor quality ; a crap [Slang] This book is a bag of wank, I am disappointed. motherism n. stereotypical belief that disconsiders in terms of intellectual and physical qualities women who stay home to look after their children correspond v. have similar qualities or a similar size, position etc to something else When I was in the 8th grade in Japan, I broke down my right hand, so I needed to write everything by my left hand and my left hand writing did not correspond to my right one. jump the shark exp. expression used to describe something that is in decline or has lost the qualities that made it popular, appealing, successful used originally in media to describe a show or a movie that is declining in popularity. E.g: I loved their ads, but with the last ones they just jump the shark. You want to reject this entry: please give us your comments (bad translation/definition, duplicate entries...)
complaint definition fda
compliant [k uh m- plahy - uh nt] /kəmˈplaɪ ənt/ Spell Syllables Examples Word Origin See more synonyms on Thesaurus.com adjective 1. complying ; obeying, obliging, or yielding, especially in a submissive way: a man with a compliant nature. 2. manufactured or produced in accordance with a specified body of rules (usually used in combination): Energy Star-compliant computers. Origin of compliant Expand 1635-1645 First recorded in 1635-45; comply + -ant Related forms Expand compliantly, adverb overcompliant, adjective precompliant, adjective quasi-compliant, adjective quasi-compliantly, adverb uncompliant, adjective uncompliantly, adverb Can be confused Expand complacent , complaisant , compliant .

4 Key Parts to a Complete Product Complaint Handling Program According to 2012 FDA statistics, drug company’s Product Complaint handling systems (21 CFR 211.198) were cited in 142 Turbo EIR observations for their deficiencies representing almost 4% of all observations. Medical device companies were cited 512 times for similar deficiencies to 21 CFR 820.198 or nearly 11% of all observations. The most frequent cause of these observations is that systems do not exist for receiving, reviewing, or evaluating complaints, or that the current procedures do not include provisions for adequate assessment of the complaints.    Maintaining an adequate complaint handling system is more than just a requirement, it is a good quality practice that can help assure your product continues to meet quality attributes after it leaves your control. Key parts of a complaint handling program include:    Written procedures  Collection and triage of complaints  Evaluation of complaints  Reporting and Trending  Written Procedures  All processes impacting GMP systems must be documented in controlled procedures and approved by the Quality Unit.    Collection and Triage  It is best to have a single point of contact for collecting complaints. Consider utilizing the same reporting system as for adverse events at this point because there is generally overlap in the evaluation of complaints for adverse events and vice-versa because some complaints may indicate quality issues (e.g. Lack of Efficacy). Each product complaint should be prioritized based on the possible implications. Complaints that may require FDA Field Alerts should receive the highest priority. Those that could indicate serious quality issues or impact patient safety should also be classified highly.    Evaluation of Complaints  The Quality Unit determines if investigation of the complaint is required and if so, how the complaint will be investigated. Written justification of the decision is documented with appropriate rationale. Whether or not return samples can be obtained is documented, as well as a review of retain samples, if appropriate. A decision to quarantine any material not already distributed should be made and documented. Critical complaints such as those that may require expedited reporting such as for certain adverse events or quality issues are expected to be reviewed immediately and possible root causes assessed.    Investigation should also include possible impact to other batches/units, the complaint history for the particular batch/unit, and a review of the manufacturing and laboratory records for possible deviations that could have led to the complaint.    Product complaint investigations should be completed within a standard timeline, generally 30 calendar days, from the time the company received the complaint. Some complaints, such as those involving third-party manufacturers, may require longer timelines. If the investigation cannot be completed on time, an interim report approved by the Quality Unit should be issued.   Reporting and Trending  Completed investigation and remediation reports should be distributed as necessary to internal groups and the company should respond appropriately to the customer/complainant. The final report should indicate if the complaint is confirmed or unconfirmed, including a documented rationale.    Appropriate corrective and preventive actions should be documented and completed for each confirmed complaint.    Complaints should be categorized so they may be tracked and trended. Categories may include defect type, system(s) impacted, product, dose, equipment, etc. Trend reports should be prepared for management review on a regular basis to identify trends and assure management is aware of issues that potentially impact product quality. The analysis should include a statistical evaluation, identification of outliers, and identify trends that indicate a need for process change or improvement.    When developing or assessing your product complaint system, consider the points above and assure your program does not end up as a statistic.    Chris Santarcangelo  Sr. Compliance Project Manager, ProPharma Group, Inc.    Photo via Wall Street Journal Blog   On the Blog: James Meckstroth is taking a closer look at Data Integrity... On the Blog: Understanding industry trends to improve your quality system. On the Blog: A look into the recently updated PDA Technical Report No. 56...
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