Critical Finding definition

Critical Finding means a deficiency, or a series of deficiencies, which has affected, or leads to a significant risk of affecting the quality of products, process and/or regulatory compliance and/ or violating quality standards as defined by cGMP which may lead to regulatory action and/or potential impact on product quality requiring immediate corrective action;
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Critical Finding means a condition which may seriously affect the quality of products, process, validity of data, purity, efficacy, integrity and/or regulatory compliance, could reasonably be expected to violate quality standards as defined in GMP, GCP, GLP and/or GPV or where there is scientific misconduct or an ethical concern identified in accordance with the dictates established in the Declaration of Helsinki, which in each case could reasonably be expected to lead to regulatory action and/or potential impact on patient safety or product quality requiring immediate corrective action.
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Critical Finding means, with respect to any Party, a finding made in an audit report, based on the results of an Audit, with respect to Services, in the case of eRT, and any services provided by Covance, in the case of Covance, prepared by the other Party, its Affiliates or any third party which is characterized as critical, and which (i) identifies any deficiency of such Party posing a threat to patient safety, (ii) is reasonably likely to result in materially adverse regulatory action by any Governmental Authority with respect to such Party, (iii) is reasonably likely to invalidate the acceptability of any Study involving the Services, in the case of eRT, or any services provided by Covance with respect to such Study, in the case of Covance, to any Customer or to any Governmental Authority; provided, however, that neither Covance nor any Person shall be permitted to characterize as critical, for purposes of the definition of “Critical Finding,” (a) any conduct of the business of the Company after the effective date of this Agreement, relating to a study set forth in the Backlog, that eRT reasonably believes to be consistent with the manner the Company conducted its business before the effective date of this Agreement, including, for the sake of clarity, conduct of the Company after the effective date of this Agreement consistent with the finding of any regulatory audit before the effective date of this Agreement or (b) any finding with respect to Services provided by the Company, unless such finding represents a meaningful and material degradation that occurred after the effective date of this Agreement.
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Examples of Critical Finding in a sentence

  • Critical Finding (CF) is defined in Critical Find Reporting Section of the BIP.

  • Critical Finding: A structural or safety related deficiency that requires immediate follow- up inspection or action.

  • Critical Findings (23 CFR 650.313, h) Purpose The purpose of the Critical Finding Bridge Report in SIIMS is to ensure that serious bridge damages or defects are reported, the necessary notifications are made to the bridge owner by the Program Manager or Team Leader, and that proper and timely action is taken to ensure the safety of the traveling public.

  • Critical Finding 2: This study reinforces other research conducted by NYSERDA that documents that TMY3 may no longer represent the current weather conditions in New York.

  • Note: The officer calling for tender may, in special case where it would be inconvenient for tenderer to deposit money into Government treasury, relax the rule and permit contractors to deposit earnest money with him in case or currency notes up to a limit of Rs.100 instead of into a treasury, Such deposits should be treated as Public Works Department Deposit.

  • Critical Finding 1: The DPS required NYSERDA to report ancillary EEPS2 savings separately, which fails to account for the entirety of savings achieved by the program.

  • Critical Finding 3: NYSERDA has recognized the importance of conducting frequent interim billing analyses for early detection in identifying potential challenges and taking corrective action as soon as possible.

  • Further information can be found in the Critical Finding Repair Procedures.

  • If inspecting a completed repair that was a Critical Finding, investigation of construction records or staff should confirm construction followed all the design requirements.

  • Critical Finding 1: To the extent that NFGDC funds its own program evaluations or influences when NYSERDA evaluates LIURP, NFGCD should advocate for continued interim billing analyses, such as the two studies currently underway for ETIP-funded projects in coordination with NYSERDAs CEF interim billing analyses for 2016 (nearly complete) and 2017 to 2018 (in progress).The EEPS2 period ran from 2012 to mid-2016, but this impact evaluation did not get started until mid-2018, a full two-years later.

Related to Critical Finding

  • Critical group means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

  • Critical Path means those Trade Contractor Work activities identified on the Construction Schedule which, if delayed, will cause a corresponding Delay in the Substantial Completion Date.

  • Critical professional work means a cornerstone or fundamental decision, requiring the exercise of sound professional judgement of the effects of a decision within a particular professional field.

  • critical functions means activities, services or operations the discontinuance of which is likely in one or more Member States, to lead to the disruption of services that are essential to the real economy or to disrupt financial stability due to the size, market share, external and internal interconnectedness, complexity or cross-border activities of an institution or group, with particular regard to the substitutability of those activities, services or operations;

  • Critical Illness means an illness, sickness or disease or corrective measure as specified in Section 6 of this policy document.

  • Critical area means an ISO Class 5 environment.

  • Critical habitat means habitat areas with which endangered, threatened, sensitive or monitored plant, fish, or wildlife species have a primary association (e.g., feeding, breeding, rearing of young, migrating). Such areas are identified herein with reference to lists, categories, and definitions promulgated by the Washington Department of Fish and Wildlife as identified in WAC 232-12-011 or 232-12-014; in the Priority Habitat and Species (PHS) program of the Department of Fish and Wildlife; or by rules and regulations adopted by the U.S. Fish and Wildlife Service, National Marine Fisheries Service, or other agency with jurisdiction for such designations. See also “Habitat of special significance.”

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • Critical areas means any of the following areas or ecosystems: wetlands, critical aquifer recharge areas, streams, fish and wildlife habitat conservation areas, frequently flooded areas, and geologically hazardous areas as defined by the Growth Management Act (RCW 36.070A.170).

  • Regulatory Information Service means a regulatory information service as defined in the FCA Handbook;

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Critical facility means a facility for which even a slight chance of flooding might be too great. Critical facilities include, but are not limited to, schools, nursing homes, hospitals, police, fire and emergency response installations, and installations which produce, use or store hazardous materials or hazardous waste.

  • Critical control point means a point, step, or procedure in a food proc- ess at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.

  • Target Audience means users on the Criteo Network who will be targeted with relevant performance advertising banners based on the Criteo Technology.

  • Adverse reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • Business Critical means any function identified in any Statement of Work as Business Critical.

  • Contractor Sensitive Information means any information provided by the Contractor to the Authority (disregarding any protective marking or assertion of confidentiality) which: is specified as Contractor Sensitive Information in Schedule 7 and has not lost its sensitivity according to the justifications and durations set out in that Schedule; and is exempt information pursuant to sections 33(1) or 36, 38 or 39 of FOISA (having regard for that purpose to the public interest there might be in disclosing such information as referred to in section 2(1)(b) of FOISA).

  • Work experience means a work activity that provides a participant with an

  • Adverse impact means any deleterious effect on waters or wetlands, including their quality, quantity, surface area, species composition, aesthetics or usefulness for human or natural uses which are or may potentially be harmful or injurious to human health, welfare, safety or property, to biological productivity, diversity, or stability or which unreasonably interfere with the enjoyment of life or property, including outdoor recreation.

  • Close Associate of a Senior Foreign Political Figure means a person who is widely and publicly known internationally to maintain an unusually close relationship with the Senior Foreign Political Figure, and includes a person who is in a position to conduct substantial domestic and international financial transactions on behalf of the Senior Foreign Political Figure;

  • senior foreign political figure is defined as a senior official in the executive, legislative, administrative, military or judicial branches of a foreign government (whether elected or not), a senior official of a major foreign political party, or a senior executive of a foreign government-owned corporation. In addition, a “senior foreign political figure” includes any corporation, business or other entity that has been formed by, or for the benefit of, a senior foreign political figure.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Technology startup company means a for profit business that

  • Adverse impact on visibility means visibility impairment which interferes with the management, protection, preservation or enjoyment of the visi- tor’s visual experience of the Federal Class I area. This determination must be made on a case-by-case basis taking into account the geographic extent, in- tensity, duration, frequency and time of visibility impairment, and how these factors correlate with (1) times of vis- itor use of the Federal Class I area, and(2) the frequency and timing of natural conditions that reduce visibility.

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • Critical infrastructure means existing and proposed systems and assets, whether physical or virtual, the incapacity or destruction of which would negatively affect security, economic security, public health or safety, or any combination of those matters.++