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? 1.32K viewsFDA 0 Votes 1 Ans Is there a distinction between a significant and a critical step? Q7A does not define “significant”? 1.57K viewsFDA 0 Votes 1 Ans What is FDA’s focus while conducting a routine surveillance inspection? 1.80K viewsFDA 0 Votes 1 Ans What prompted development of the Concept of Operations (ConOps)? 1.59K viewsFDA 0 Votes 1 Ans How does FDA communicate the final inspection classification? 1.63K viewsFDA 0 Votes 1 Ans Is the agency updating internal policies and procedural documents to reflect the ConOps? 1.64K viewsFDA 0 Votes 1 Ans Will the ConOps help address problems at manufacturing facilities that have impacted approval of drug applications? 1.75K viewsFDA 0 Votes 1 Ans Is there a list of CDER-approved drug manufacturing equipment? 1.65K 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? 1.37K viewsFDA 0 Votes 1 Ans What does an FDA investigator do upon completing an inspection? 1.78K viewsFDA 0 Votes 1 Ans Does FDA expect firms to investigate both released and rejected lots for potential recalls? 1.70K 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? 1.52K 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? 1.54K viewsFDA 0 Votes 1 Ans What if the improper storage conditions include exposure to toxic fumes or radiation? 1.80K viewsFDA 0 Votes 1 Ans How can consumers identify products that may be violative? 1.68K viewsFDA 0 Votes 1 Ans Is it possible to obtain an exemption from specific provisions of the GLPs for special nonclinical laboratory studies? 1.62K viewsFDA 0 Votes 1 Ans What are FDA’s concerns about the use of raw manure as fertilizer in crop production? 1.37K viewsFDA 0 Votes 1 Ans What research has FDA already done into the survival of pathogens, such as E. coli O157:H7, in soil amended with raw manure? 1.77K viewsFDA 0 Votes 1 Ans What would the FDA think about test documents with actual results typed in instead of being handwritten? 1.87K viewsFDA 0 Votes 1 Ans Auditing Systems for 21 CFR Part 11- Validation and Qualification – What are differences between Validation and Qualification? 1.58K viewsFDA « Previous 1 2 3 4 5 6 … 75 76 Next » Question and answer is powered by anspress.net
