FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Please expand on what is acceptable as true copies. Do you mean actual reproductions in place of originals, scanned records, or validated computer system accepted by the FDA? 1.66K viewsFDA 0 Votes 1 Ans Should an Excel spreadsheet be validated that is used for trending of stability data? 1.57K viewsFDA 0 Votes 1 Ans How can consumers identify products that may be violative? 1.52K viewsFDA 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 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 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 What if the improper storage conditions include exposure to toxic fumes or radiation? 1.31K viewsFDA 0 Votes 1 Ans What prompted development of the Concept of Operations (ConOps)? 1.77K viewsFDA 0 Votes 1 Ans How does FDA communicate the final inspection classification? 1.33K viewsFDA 0 Votes 1 Ans Is the agency updating internal policies and procedural documents to reflect the ConOps? 1.57K viewsFDA 0 Votes 1 Ans What are FDA’s concerns about the use of raw manure as fertilizer in crop production? 1.78K viewsFDA 0 Votes 1 Ans Auditing Systems for 21 CFR Part 11-Validation of Software Programs – We have a GcP app on a server. When we need to install some additional utility apps and supporting app on that server such as Adobe Reader, Word and Firefox, do we need to qualify or validate these software programs? 1.45K viewsFDA « Previous 1 2 … 73 74 75 76 Next » Question and answer is powered by anspress.net
