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Correctional clothes, shoes, etc. of calmedfoundation.org

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  •  Correctional clothes, shoes, etc. 
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  • Quality policy and objectives 	The [quality policy] [quality objectives] [was] [were] not established by management withQuality policy and objectives The [quality policy] [quality objectives] [was] [were] not established by management with executive responsibility. Specifically,
    Design input documentation Design input requirements were not [adequately] documented. Specifically,
    Lack/Inad procedure-Monitoring/Control of Validated Proces Procedures for monitoring and control of process parameters for a validated process have not been [adequately] established. Specifically,
    Approval, inadequate purchasing data Purchasing data that clearly describe or reference specified requirements for purchased or ...
    31.07.2017
    Correctional clothes, shoes, etc.        Quality policy and objectives 	The [quality policy] [quality objectives] [was] [were] not established by management with calmedfoundation.org 
    Review and evaluation for investigation	Not all complaints have been [adequately] reviewed and evaluated to determine whReview and evaluation for investigation Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically,
    Procedures for product review,disposition lack of/inadequate Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been [adequately] established. Specifically,
    Design transfer Procedures for design transfer have not been [adequately] established. Specifically,
    Sampling plans Sampling plans are not [written][based on valid statistical rationale] ...
    31.07.2017
    Correctional clothes, shoes, etc.        Review and evaluation for investigation	Not all complaints have been [adequately] reviewed and evaluated to determine wh calmedfoundation.org 
    Lack of or inadequate DHR procedures 	Procedures for device history records have not been [adequately] established.  SpeLack of or inadequate DHR procedures Procedures for device history records have not been [adequately] established. Specifically,
    Management review - Lack of or inadequate procedures Procedures for management review have not been [adequately] established. Specifically,
    Design control - no procedures Procedures for design control have not been established. Specifically,
    Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established. Specifically,
    Lack ...
    31.07.2017
    Correctional clothes, shoes, etc.        Lack of or inadequate DHR procedures 	Procedures for device history records have not been [adequately] established.  Spe calmedfoundation.org 
    ""
    Notification of FDA of termination of investigator Failure to notify FDA of the ending, for cause, of an investigator s participation in an investigation. Specifically,
    Record retention requirement Records and reports were not retained for two years after [marketing application approval] [discontinuance of the investigation and notification of FDA]. Specifically
    Annual report Failure to submit to FDA [within 60 days of the anniversary date that the IND went into effect] an annual report of the investigation. Specifically,
    Required label statement The immediate package of the in ...
    31.07.2017
    Correctional clothes, shoes, etc.        " calmedfoundation.org 
    QAU: problems affecting study integrity	The quality assurance unit failed to immediately bring to the attention of the sQAU: problems affecting study integrity The quality assurance unit failed to immediately bring to the attention of the study director and management any problems found during the course of an inspection which are likely to affect study integrity. Specifically,
    QAU: SOPs and required records The quality assurance unit failed to maintain and make available for inspection required records regarding its responsibilities and procedures and the method of indexing such records. Specifically,
    Facility: article receipt and storage areas The testing facility does not provide separate areas, as n ...
    31.07.2017
    Correctional clothes, shoes, etc.        QAU: problems affecting study integrity	The quality assurance unit failed to immediately bring to the attention of the s calmedfoundation.org 
    Initial and continuing review	Failure to assure that an IRB [complying with applicable regulatory requirements] was respInitial and continuing review Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the initial and continuing review and approval of a clinical study. Specifically,
    Changes in research Not all changes in research activity were approved by an Institutional Review Board prior to implementation. Specifically,
    Understandable language The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject s representative. Specifically,
    Personnel: appropriat ...
    31.07.2017
    Correctional clothes, shoes, etc.        Initial and continuing review	Failure to assure that an IRB [complying with applicable regulatory requirements] was resp calmedfoundation.org 
    Conflict of interest	The IRB allowed a member to participate in the IRB s [initial] [continuing review] of a project in Conflict of interest The IRB allowed a member to participate in the IRB s [initial] [continuing review] of a project in which the member had a conflicting interest. Specifically,
    Confidentiality, FDA inspection of records There was no statement in the informed consent document that [described the extent, if any, to which confidentiality of records identifying the subject would be maintained] [noted the possibility that the Food and Drug Administration might inspect the records]. Specifically,
    QAU: authorize deviations from protocols or SOPs The quality assurance unit failed to determin ...
    31.07.2017
    Correctional clothes, shoes, etc.        Conflict of interest	The IRB allowed a member to participate in the IRB s [initial] [continuing review] of a project in  calmedfoundation.org 
    Donor deferral	The standard operating procedure fails to include a written description of the donor deferral process.  SDonor deferral The standard operating procedure fails to include a written description of the donor deferral process. Specifically,
    Deferred or not suitable Failure to notify the donor [that the donor is deferred or determined not to be suitable] [of the reason for deferral]. Specifically,
    Follow up and counseling Failure to provide appropriate information concerning medical follow-up and counseling. Specifically,
    Further testing Failure to further test each donation found to be reactive to a screening test. Specifically,
    Donor Deferral - reentry The method or process used to r ...
    31.07.2017
    Correctional clothes, shoes, etc.        Donor deferral	The standard operating procedure fails to include a written description of the donor deferral process.  S calmedfoundation.org 
    SOP compliance	Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640.  SpecificaSOP compliance Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640. Specifically,
    Accurate measurement of quantity of blood The standard operating procedure fails to include a written description of the blood collection procedure, including in-process precautions taken to measure accurately the quantity of blood removed from the donor. Specifically,
    Labeling procedures to avoid labeling mix-ups The standard operating procedure fails to [include a written description of the labeling procedures] [include safeguards to avoid labeling mix-ups]. Sp ...
    31.07.2017
    Correctional clothes, shoes, etc.        SOP compliance	Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640.  Specifica calmedfoundation.org 
    Maintenance - completeness	The [manufacturing] [distribution] records [are not legible and indelible] [do not detail theMaintenance - completeness The [manufacturing] [distribution] records [are not legible and indelible] [do not detail the various steps of manufacture of the product]. Specifically,
    Who must report - manufacturer Failure to submit [a] biological deviation [report] [reports]. Specifically,
    Adverse Reaction- Reports of Investigations Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained. Specifically,
    Donor qualifying tests & measurements The standard operating procedure fails to include written descriptions of met ...
    31.07.2017
    Correctional clothes, shoes, etc.        Maintenance - completeness	The [manufacturing] [distribution] records [are not legible and indelible] [do not detail the calmedfoundation.org 
    Maintained and followed	Written standard operating procedures including all steps to be followed in the [collection] [prMaintained and followed Written standard operating procedures including all steps to be followed in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components for [homologous transfusion] [autologous transfusion] [further manufacturing purposes] are not always [maintained] [followed] [maintained on the premises]. Specifically,
    Thorough investigations "Failure to [perform a thorough investigation] [make a record of the conclusions and follow-up] of [an unexplained discrepancy] [a failure of a lot or unit to meet any of its specifications]. ...
    31.07.2017
    Correctional clothes, shoes, etc.        Maintained and followed	Written standard operating procedures including all steps to be followed in the [collection] [pr calmedfoundation.org 


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