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? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans The definition of “nonclinical laboratory study” excludes field trials in animals. What is a field trial in animals? 1.74K 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? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans How long does FDA allow a laboratory to effect corrective actions after an inspection has been made? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans What background materials are used by agency investigators to prepare for a GLP inspection? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA inspect international nonclinical laboratories once every two years? 1.72K 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? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Can FDA investigators take photographs of objectionable practices and conditions? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a GLP EIR be reviewed by laboratory management prior to issuance? 1.54K 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? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans What kinds of domestic toxicology laboratory inspections does FDA perform and how frequently are they done? 1.92K viewsDrugsPharmaceutical 0 Votes 1 Ans Will a laboratory subsequently be notified of GLP deviations not listed on the FDA-483? 1.75K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the usual procedure for the issuance of a form FDA-483? 1.78K viewsDrugsPharmaceutical 0 Votes 1 Ans What studies are required to be listed on the master schedule sheet? 1.97K 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? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the QAU have to monitor compliance with regulations promulgated by other government agencies? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans Must the QAU keep copies of all protocols and amendments and SOPs and amendments? 1.78K viewsDrugsPharmaceutical 0 Votes 1 Ans As a QAU person, I have no expertise in the field of pathology. How do I audit pathology findings? 1.65K 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? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Can the study director be the chief executive of a nonclinical laboratory? 1.67K viewsDrugsPharmaceutical « Previous 1 2 … 16 17 18 19 20 … 82 83 Next » Question and answer is powered by anspress.net
