Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Can FDA investigators take photographs of objectionable practices and conditions? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a GLP EIR be reviewed by laboratory management prior to issuance? 1.46K 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? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans What kinds of domestic toxicology laboratory inspections does FDA perform and how frequently are they done? 1.81K viewsDrugsPharmaceutical 0 Votes 1 Ans Will a laboratory subsequently be notified of GLP deviations not listed on the FDA-483? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the usual procedure for the issuance of a form FDA-483? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans What studies are required to be listed on the master schedule sheet? 1.84K 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? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the QAU have to monitor compliance with regulations promulgated by other government agencies? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Must the QAU keep copies of all protocols and amendments and SOPs and amendments? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans As a QAU person, I have no expertise in the field of pathology. How do I audit pathology findings? 1.58K 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? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Can the study director be the chief executive of a nonclinical laboratory? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the QAU have to be composed of technical personnel? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans Should current summaries of training and experience list attendance at scientific and technical meetings? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans For what sequence in the supervisory chain should position descriptions be available? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA preannounce all GLP inspections? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a laboratory’s responsibility for corrective action listed on a FDA-483 begin at the conclusion of an inspection or upon receipt of correspondence from the originating bureau in which corrective action is requested? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans How many copies of the complete laboratory SOPS are needed? 1.43K viewsDrugsPharmaceutical « Previous 1 2 … 16 17 18 19 20 … 79 80 Next » Question and answer is powered by anspress.net
