Type I Incident definition

Type I Incident shall be defined as an unexpected result that has potential serious impact on product safety, identity, strength, quality, purity, efficacy or manufacturing/testing process. Examples of Type I Incidents include final product sterility and stability failure, media fill failure, pyrogen specification exceeded for bulk or final container and inadequate viral inactivation process. For purposes of this Agreement, a “Type II Incident” shall be defined as an unexpected result that has the potential to affect product safety, identity, strength, quality, purity, efficacy or manufacturing/testing process. Examples of Type II Incidents include clean steam exceeding action level for LAL and Presterile in-process bioburden exceeding action level.
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Examples of Type I Incident in a sentence

  • Implement procedures to report all requests from the National Interagency Fire Center (NIFC), National Incident Coordination Center , and subordinate Geographic Area Coordination Centers for certified DoD civilian fire fighters to support Type I Incident Management Teams to the appropriate supported Combatant Commander.

  • Once a wildfire burns beyond the initial and extended attack capabilities of local forces, the local responsible agency often requests management assistance in the form of a local Incident Management Team or a National Type II or Type I Incident Management Team.

  • Due to the complexities involved, a Type I Incident Management Team was ordered.

  • Event TypeCounty-wide, significantTotal Expected CYs15,000-30,000 CYsNumber of DMS1, PossiblyRequested ResourcesLocal ContractorsNumber of Hauling Equipment20 ea., 10-24 CY TrucksEstimated Project Timeline20-30 Days Type I Incident Involves a declared disaster, which requires an extensive County and State response where the State and local governments are clearly overwhelmed.

  • This code, published in conformity with O.R.C. 3313.661, specifies the school’s expectations.

  • ODF maintains three Type I Incident Management Teams statewide that are available for dispatch to any area of Oregon with an estimated time of arrival of 8-10 hours maximum from time of dispatch.

  • Even when "standards and procedures outline certain requirements for fire suppression, they do not eliminate discretion because they do not tell firefighters how to fight the fire." Id. Here, plaintiff does not dispute that the Forest Service named a Type I Incident Commander to oversee a Type I Incident Management Team, giving him the authority, responsibility, and discretion to fight what eventually became a 14,000 acre fire based on his determined strategy and available tactics.

  • Receive a simple majority of the vote of Incident Commanders present at an IC meeting after being proposed by a Type I Incident Commander.

  • The recommended option is to remove endorsements for drivers of special-type vehicles.

  • Simulations may not be counted toward meeting this requirement.Receive a simple majority of the vote of Incident Commanders present at an IC meeting after being proposed by a Type I Incident Commander.Comment [CKR45]: Removed this requirement as there is no structure for an IC meeting.

Related to Type I Incident

  • Data Incident means a breach of Google’s security leading to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, Customer Data on systems managed by or otherwise controlled by Google.

  • Critical incident means an occurrence or set of events inconsistent with the routine operation of a facility, service setting, or otherwise routine care of a consumer. Critical incidents specifically include but are not necessarily limited to the following: adverse drug events; self-destructive behavior; deaths and injuries to consumers, staff and visitors; medication errors; residential consumers that are absent without leave (AWOL); neglect or abuse of a consumer; fire; unauthorized disclosure of information; damage to or theft of property belonging to consumers or the facility; other unexpected occurrences; or events potentially subject to litigation. A critical incident may involve multiple individuals or results.

  • Cyber incident means actions taken through the use of computer networks that result in a compromise or an actual or potentially adverse effect on an information system and/or the information residing therein.

  • Unusual Incident means incidents involving serious illness or accidents, death of an individual, injury or illness of an individual requiring inpatient or emergency hospitalization, suicide attempts, a fire requiring the services of a fire department, an act of physical aggression, or any incident requiring abuse investigation.

  • Nuclear incident means any occur- rence including an extraordinary nuclear oc- currence or series of occurrences at the loca- tion or in the course of transportation caus- ing bodily injury, sickness, disease, or death, or loss of or damage to property, or loss of use of property, arising out of or resulting from the radioactive, toxic, explosive, or other hazardous properties of the radioactive material.(b) Any occurrence including an extraor- dinary nuclear occurrence or series of occur- rences causing bodily injury, sickness, dis- ease or death, or loss of or damage to prop- erty, or loss of use of property, arising out of or resulting from the radioactive, toxic, ex- plosive or other hazardous properties of

  • Minor incident means an occurrence involving a consumer during service provision that is not a major incident and that:

  • Privacy Incident means a violation or imminent threat of violation of security policies, acceptable use policies, or standard security practices, involving the breach of Personally Identifiable Information (PII), whether in electronic or paper format.

  • serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:

  • Terrorist Incident means an act of violence by any person acting on behalf of or in connection with any organization which is generally recognized as having the intent to overthrow or influence the control of any government, that is deemed terrorism by the United States Government other than civil disorder or riot, that is not an act of war, declared or undeclared, that results in Loss of life or major damage to property.

  • Pollution Incident means an occurrence or series of occurrences having the same origin, which results or may result in a discharge of oil and/or hazardous and noxious substances and which poses or may pose a threat to the marine environment, or to the coastline or related interests of one or more States, and which requires emergency action or other immediate response;

  • Reportable Incident means a situation in which a Client has suffered Harm or experienced a Close Call or any Hazard that could lead to Client harm, all in accordance with Schedule “D”, Appendix 4.

  • Environmental Incident means, in relation to a Ship:

  • Cyber Security Incident means any malicious or suspicious event that disrupts, or was an attempt to disrupt, the operation of those programmable electronic devices and communications networks including hardware, software and data that are essential to the Reliable Operation of the Bulk Power System.++

  • Security Incident means any known successful or unsuccessful attempt by an authorized or unauthorized individual to inappropriately use, disclose, modify, access, or destroy any information or interference with system operations in an information system.

  • Successful Security Incident means a Security Incident that results in the unauthorized Access, Use, Disclosure, modification, or destruction of information or interference with system operations in an Information System.

  • Discrepancies incident to shipment means any differences (e.g., count or condition) between the items documented to have been shipped and items actually received.

  • Major incident means an occurrence involving a consumer during service provision that:

  • Targeted Unsuccessful Security Incident means an Unsuccessful Security Incident that appears to be an attempt to obtain unauthorized Access, Use, Disclosure, modification or destruction of the Covered Entity’s Electronic PHI.

  • Unsuccessful Security Incident means a Security Incident such as routine occurrences that do not result in unauthorized Access, Use, Disclosure, modification, or destruction of information or interference with system operations in an Information System, such as: (i) unsuccessful attempts to penetrate computer networks or services maintained by Business Associate; and (ii) immaterial incidents such as pings and other broadcast attacks on Business Associate's firewall, port scans, unsuccessful log-on attempts, denials of service and any combination of the above with respect to Business Associate’s Information System.

  • Data Security Incident means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, Agreement Personal Data transmitted, stored or otherwise Processed;

  • Catastrophic Damage as used hereunder is major change or damage to In- cluded Timber on Sale Area, to Sale Area, to access to Sale Area, or a combination thereof:

  • Aggravated circumstances means circumstances in which a parent:

  • Technical Failure means the discontinuation of Development or Commercialization of a Product for technical, scientific, medical or regulatory reasons, including, but, not limited to, unacceptable preclinical toxicity, demonstration of a side effect profile significantly worse than currently marketed products, or inability to manufacture in an acceptable purity or for an acceptable price.

  • Catastrophic illness or "Injury" means an illness or injury that is expected to incapacitate the employee for an extended period of time, or that incapacitates a member of the employee's family which incapacity requires the employee to take time off from work for an extended period of time to care for that family member, and taking extended time off work creates a financial hardship for the employee because he or she has exhausted all of his or her sick leave and other paid time off.

  • Catastrophic Event means a rare circumstance in which mass casualties and/or significant property damage has occurred or is imminent (e.g. September 11th, hurricanes, earthquakes greater than 6.1 on the Richter scale)

  • service well means a well drilled or completed for the purpose of supporting production in an existing field. Wells in this class are drilled for the following specific purposes: gas injection (natural gas, propane, butane or flue gas), water injection, steam injection, air injection, salt water disposal, water supply for injection, observation or injection for combustion.