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;
Sample 1Sample 2Sample 3
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.
Sample 1
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.
Sample 1

Examples of Critical Finding in a sentence

  • BIP Leads should check to see if the structure needs a new Load Rating, see Re-Load Rating during Inspection□ Review Element condition and quantitieso Load path Elements with quantities in Condition State 4 indicate an NBI Superstructure or Substructure = 4.□ Critical Findingo If the Bridge Inspection Report documents a Critical Finding, return the Report to the Inspector until a detailed/measurable/actionable Report and process has been completed.o Existing Critical Finding Notification is posted in BrM.

  • Critical Finding: a finding or a combination of findings that results in a significant negative effect on data quality or defensibility, if not corrected.

  • Incident information shall also be entered in the interim CFDR tracking system by the Bridge Repair Engineer within five (5) business days after determination that the event qualifies as a CFDR event.Initial notification for a critical finding is followed up by completing a Critical Finding Damage Report (CFDR).

  • Unless there was a Critical Finding or an urgent maintenance inspection was requested by the DME, an immediate maintenance inspection is not required but the guidelines below should be followed by district inspection forces: • Priority A or “A Flags” should be cleared within 30 days of the work being completed.• Priority B or “B Flags” should be cleared within 90 days of the work being completed.• Priority C or “C Flags” should be cleared whenever convenient or within 365 days of the work being completed.

  • As part of the initial notification (Critical Finding Report), provide a detailedwritten report of the deficiency supplemented with drawings, sketches and photographs as is necessary to illustrate the problem.

  • Critical Finding: The Department of Radiology defines a critical finding as any clinically significant finding that has the potential to alter a patient’s treatment/management and may require immediate clinical intervention to avoid morbidity or mortality.A defined list of “critical Findings” has been established and approved by the Chairman of Radiology.

  • If the at-bridge posting sign is missing or illegible, then the BITL shall issue a Critical Finding.

  • Critical Finding 2 and 3 A non-commercial sponsor organisation had two critical findings identified during their inspection.

  • On identifying an initial or more severe than previously reported Critical Finding – immediately secure the bridge as necessary to protect the travelling public (TL)2.

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

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 (C) means any equipment, medications or supplies critical for lifesaving patient care and which by its absence would jeopardize patient care.

  • 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 or “CI” means Diagnosis of any of the following Covered Conditions which occur directly as a result of illness, and first occur after the Effective Date of Insurance:

  • Critical area means an ISO Class 5 environment.

  • Critical habitat - means the following river reaches and their 100 year floodplains: the Gunnison River downstream of the Uncompahgre River confluence, the Colorado River downstream of the exit 90 north bridge from I-70, the White River downstream of Rio Blanco Dam, the Green River downstream of the Yampa River confluence, and the Yampa River downstream of the Colo 394 bridge.

  • Critical Component means, in respect of a weapons system referred to in the definition of Prohibited Defense Contract, a component used specifically in the production of the weapon system or plays a direct role in the lethality of the weapon system.

  • 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 Takeover Rules.

  • 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.

  • 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.

  • Work experience means an activity in the unpaid employment component in which the participant works without pay at a job site to develop good work habits and basic vocational skills that enhance the likelihood the participant will become employed. "Work experience" is available through private for-profit businesses, nonprofit organizations, or public agencies.¶

  • 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.

  • 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.

  • 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.++

  • Directory information means information contained in an education record of a student which would not generally be considered harmful or an invasion of privacy if disclosed. It includes, but is not limited to: the student’s name, address, telephone listing, electronic mail address, photograph, date and place of birth, major field of study, dates of attendance, grade level, enrollment status (i.e., full-time or part-time), participation in officially recognized activities and sports, weight and height of members of athletic teams, degrees, honors and awards received, and the most recent educational agency or institution attended. It also includes the name, address, and telephone number of the student’s parent(s). Directory information does not include:

  • Competitively Sensitive Information means non-public information and data specific to a utility customer which the utility acquired or developed in the course of its provision of utility services. This includes, without limitation, information about which customers have or have not chosen to opt out of community choice aggregation service. (See D.97-12-088, App. A, Part I.D.)

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.