Field Alert Report

Field Alert Reports of manufacturing defects must be made to the local district office vdthin 3 days of discovery of a problem with a distributed product. 

Compliance inspections are for the purpose of evaluating or verifying compliance corrective actions after a problem has been identified and regulatory action has been taken. Compliance inspections cover the areas found deficient and subjected to corrective actions. One type of compliance inspection is a for-cause inspection, which is conducted to investigate a specific problem that has come to the attention of the FDA. The sources that trigger a compliance inspection include field alert reports, industry complaints, and recalls. 

Standing Operating Procedures for NDA/ANDA Held Alert Reports. (Issued October 30,1998, posted November 2,1998).This MaPP establishes a system for evaluating NDA and ANDA Field Alert Reports and provides instructions to the responsible CDER units for handling those reports. 

In the case where the product fails to meet the specifications under the non-ICH conditions, irrespective of whether it also fails under the ICH conditions, a thorough investigation in accordance with CGMP should be performed and appropriate corrective actions should be taken, including a Field-Alert Report and recall of the affected product from the marketplace if warranted. 

For those products which are the subject of regulatory applications, regulations require submittal within 3 working days of a Field Alert Report (FAR) concerning the failure of a distributed batch to meet any of the specifications established in the application. 

Is a 72 h field alert needed A medical device report (MDR) Biologic product errors and accident (E/ A) report ... 

The paper reports some of the initiatives undertaken in the field of chemical accidents of industrial origin. The accent was on the necessity to share available information between countries about the occurrence of the events and lessons learned. It is recognized that there is still the need to improve the harmonization of reporting tools towards the homogenization of data collection. The issue of possible transboundary effects of chemical accidents has not been covered in this report. However, a number of reporting and alert systems have been established in Conventions signed by representatives of several countries in Europe and world-wide. 

Japanese studies toward an atomic bomb began first within the military. The director of the Aviation Technology Research Institute of the Imperial Japanese Army, Takeo Yasuda, a lieutenant general and an alert electrical engineer, conscientiously followed the international scientific literature that related to his field in the course of his reading in 1938 and 1939 he noticed and tracked the discovery of nuclear fission. In April 1940, foreseeing fission s possible consequences, he ordered an aide who was scientifically trained. Lieutenant Colonel Tatsusaburo Suzuki, to prepare a fuU report Suzuki went to work with a will... 

The latter regularly includes a section called current awareness which lists recent literature relevant to drug safety. Another journal which is very useful in that respect is Reactions Weekly which is primarily an alerting service based on case reports but also covers topical issues and news in the field. All these journals are available in both paper and electronic formats and access is essential for anyone working in the field. 

An exhaustive analysis of 2995 molecule pairs extracted from the 98.1 version of Bioster database indicated that similarity measures based on 2D molecular fingerprints or electrostatic field descriptors were complementary although 2D methods could be adequate for similarity analyses [55]. To evaluate a range of similarity measures among synthetic substances and natural products, the Willett group also used 5024 compounds from Bioster database as well as sets of selected bioactive compounds from the more populous Chemical Abstract Service, ID-Alert, MACCS Drug Data Report, and NCI AIDS databases [56]. 

The implementation of a voluntary blameless reporting system is a deep cultural intervention in an organization that legitimizes transparency of system vulnerability, nurtures an alert field, and empowers front-line providers to expose risks. In turn, the front line learns to expect responses from managers at the blunt end to support the work of improvement. The few organizations in health care that have developed reporting systems believe that the effort is 75 percent social and only 25 percent technical (personal communication from Anne-Claire France, former director of the Center for Healthcare Improvement, Memorial Hermann Healthcare... 

The separation and characterization of environmental pollutants in aqueous samples is a demanding task. The concentration of contaminants is usually very low (typical < 10 xg/L) and the matrices may be complex. GC is necessary for analyte separation while, in most cases, IR is very suitable for this purpose because of its unique molecular fingerprinting properties. Applications of GC/ FTIR are found in a wide variety of analytical fields. Most applications have been reported on the analysis of environmental samples. A representative example of what can be achieved nowadays is the identification of pesticides in water samples at the European alert and alarm levels of 0.1-1 ng/ml, as described by Hankemeier et al., ... 

Reduce the internal tolerance for security anomalies, such as overdue or missing vehicles, perimeter of physical plant intrusions, unverified visitors, evidence of tampering, and the like. Report suspicious activities, especially those fitting any profiles presented in threat alert advisories, immediately to law enforcement and/or the nearest FBI field office. 

Some researchers have reported that creative individuals question accepted norms and assumptions and are alert to gaps in knowledge in their domain. They commonly have the ability to recognize good problems in their field and to apply themselves to solving these problems while ignoring others. 

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