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.

  • We, here, are reminded of Luis Pasteur’s guess that ‘life’ generates matter and the conventional scientist’s view of vice-versa may not be true.

  • 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.

  • NRCC levels equal disaster type (e.g., in a Type I Incident, the NRCC will be stood up at a Level I).Activation Organization Structure‌ The Director of Disaster OperationsThe Director of Disaster Operations (DDO) is an incident specific role assigned to a seniorFEMA official by the FEMA Administrator to coordinate and synchronize all Headquarters activities for credible threats and during major disaster or emergency activations.

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

  • HOURSTX-TXS-012009 To: All Incident Personnel, Southeast Texas Fire Complex‌ As Southern Area National Type I Incident Commander, I am committed to a policy of “zero tolerance” of inappropriate behavior during incident operations.

  • The five types of incidents per ICS are:• Type I Incident - Highly Complex National Interest (National)• Type II Incident - Very Complex Regional to National (District)• Type III Incident - Non-Routine Local Interest (Unit Level)• Type IV Incident - Routine (Unit Level)• Type V Incident - Initial (Unit Level) Section 4500 of the NWACP has a general hierarchy list of response priorities for the Pacific Northwest.

  • Applied solar insolation therefore has no significant impact on the results.

  • Expanding or complex incidents may require transitioning incident management to a Type III, Type II, or Type I Incident Management Team (IMT).

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 the facility, or the 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; 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 a 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.

  • 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:

  • 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;

  • Environmental Incident means, in relation to each 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 the attempted or successful unauthorized access, use, disclosure, modification, or destruction of 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:

  • 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:

  • 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 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.