Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Necropsies are done by prosecutors trained by and working under the supervision of a pathologist. The necropsy data are recorded by the prosecutor on data sheets, and when making the final report, the pathologist summarizes the data collected by the prosecutor as well as by him/herself. What constitutes the raw data in this example? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans The definition of “nonclinical laboratory study” excludes field trials in animals. What is a field trial in animals? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans A laboratory conducts animal studies to establish a baseline set of data for a different test species/strain. No test article is administered but the toxicology laboratory facilities and procedures will be used and the resulting data may eventually be submitted do the agency as part of a research or marketing permit. Are the studies considered to be nonclinical laboratory studies that are covered by the GLPs? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans How long does FDA allow a laboratory to effect corrective actions after an inspection has been made? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans What background materials are used by agency investigators to prepare for a GLP inspection? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA inspect international nonclinical laboratories once every two years? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans The GLP Compliance Program requires the FDA investigator to select an ongoing study in order to inspect current laboratory operations what criteria are used to select the study? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Can FDA investigators take photographs of objectionable practices and conditions? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a GLP EIR be reviewed by laboratory management prior to issuance? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Should GLP investigators comment on the scientific merits of a protocol or the scientific interpretation given in the final report? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans What kinds of domestic toxicology laboratory inspections does FDA perform and how frequently are they done? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Will a laboratory subsequently be notified of GLP deviations not listed on the FDA-483? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the usual procedure for the issuance of a form FDA-483? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans What studies are required to be listed on the master schedule sheet? 1.76K viewsDrugsPharmaceutical 0 Votes 1 Ans Can an individual who is involved in a nonclinical laboratory study perform QAU functions for portions of the study that the individual is not involved with? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the QAU have to monitor compliance with regulations promulgated by other government agencies? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Must the QAU keep copies of all protocols and amendments and SOPs and amendments? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans As a QAU person, I have no expertise in the field of pathology. How do I audit pathology findings? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans The GLPs permit the designation of an “acting” or “deputy” study director to be responsible for a study when the study director is on leave. Should study records identify the designated “deputy” or “acting” study director? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Can the study director be the chief executive of a nonclinical laboratory? 1.54K viewsDrugsPharmaceutical « Previous 1 2 … 16 17 18 19 20 … 82 83 Next » Question and answer is powered by anspress.net
