Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Is it possible to obtain an exemption from specific provisions of the GLPs for special nonclinical laboratory studies? 1.41K viewsFDA 0 Votes 1 Ans Will a laboratory subsequently be notified of GLP deviations not listed on the FDA-483? 1.63K viewsFDA 0 Votes 1 Ans What kinds of domestic toxicology laboratory inspections does FDA perform and how frequently are they done? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans How long does FDA allow a laboratory to effect corrective actions after an inspection has been made? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans Has FDA established guidelines for the frequency of calibration of equipment (balances) used in nonclinical laboratory studies? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans What amount of detail should be included in the standard operating procedures (SOPs)? 1.63K viewsFDA 0 Votes 1 Ans To what extent are computer programs to be documented as SOPS? 1.43K viewsFDA 0 Votes 1 Ans What are the GLP requirements for labeling of reagents purchased directly from manufacturers? 1.73K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA reject nonclinical laboratory studies that have not been conducted in full compliance with the GLPs? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans How soon after an employee provides notice of the need for leave must an employer notify an employee that the leave will be designated and counted as FMLA leave? 1.50K viewsHuman Resources 0 Votes 1 Ans Will the ConOps help address problems at manufacturing facilities that have impacted approval of drug applications? 1.78K viewsFDA 0 Votes 1 Ans Is there a list of CDER-approved drug manufacturing equipment? 1.50K viewsFDA 0 Votes 1 Ans Does FDA prefer one type of material over another (e.g., polyvinylidene difluoride over stainless steel) for construction of recirculating loops in water for injection (WFI) systems? 1.67K viewsFDA 0 Votes 1 Ans Does FDA prefer one type of material over another (e.g., polyvinylidene difluoride over stainless steel) for construction of recirculating loops in water for injection (WFI) systems? 1.39K viewsFDA 0 Votes 1 Ans What does an FDA investigator do upon completing an inspection? 1.72K viewsFDA 0 Votes 1 Ans Does FDA expect firms to investigate both released and rejected lots for potential recalls? 1.51K viewsFDA 0 Votes 1 Ans How do the Part 11 regulations and “predicate rule requirements” (in 21 CFR Part 211) apply to the electronic records created by computerized laboratory systems and the associated printed chromatograms that are used in drug manufacturing and testing? 1.31K viewsFDA 0 Votes 1 Ans How does the FDA interpret the regulations (21 CFR Part 211) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents? 1.19K views 0 Votes 1 Ans What if the improper storage conditions include exposure to toxic fumes or radiation? 1.31K viewsFDA 0 Votes 1 Ans What is the FDA doing to ensure the safety of drugs coming from Japan? 1.62K viewsDrugsPharmaceutical « Previous 1 2 … 275 276 277 278 279 … 283 284 Next » Question and answer is powered by anspress.net
