FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What is an O/O account responsible for? 1.54K viewsFDA 0 Votes 1 Ans What is an OC account responsible for? 1.45K viewsFDA 0 Votes 1 Ans How do I tell what kind of account I am logged in with? 1.49K viewsFDA 0 Votes 1 Ans How often do I need to change my password in FURLS? 1.36K viewsFDA 0 Votes 2 Ans What is a clinical trial? 1.77K viewsFDA 0 Votes 1 Ans What is a recall? 1.56K viewsFDA 0 Votes 1 Ans Are OTC drugs subject to the same recall provisions as prescription drugs? 1.31K viewsFDA 0 Votes 1 Ans What happens if a firm does not voluntarily recall a defective product? 1.44K viewsFDA 0 Votes 1 Ans Do CGMPs require that forced degradation studies always be conducted of the drug product when determining if a drug product stability test method is stability-indicating? 1.50K viewsFDA 0 Votes 1 Ans When performing the USP <788> Particulate Matter in Injections test for a Large Volume Parenteral (LVP), is it acceptable to take the average among the units tested to determine if the batch meets its specification for this attribute? 1.69K viewsFDA 0 Votes 1 Ans Would a paramagnetic or laser oxygen analyzer be able to detect all possible contaminants or impurities in a medical gas? 1.60K viewsFDA 0 Votes 1 Ans Are there any challenges with facilities complying with global cGMP regulations? 1.61K viewsFDA 0 Votes 1 Ans In which intervals do systems have to be validated? 1.60K viewsFDA 0 Votes 1 Ans Is it necessary to approve hardware and software suppliers formally? 1.49K viewsFDA 0 Votes 1 Ans What is standard software? Does standard software have to be validated? 1.67K viewsFDA 0 Votes 1 Ans Traceability matrix – what is necessary? Must an end user have a traceability matrix, administrate it and validate it? 1.55K viewsFDA 0 Votes 1 Ans Which significance do the PIC/S Guidances have? 1.56K viewsFDA 0 Votes 1 Ans Is there a distinction between a significant and a critical step? Q7A does not define “significant”. 1.64K viewsFDA 0 Votes 1 Ans Regarding computer validation, is it necessary to second check all data into the computer system or only the critical data? 1.45K viewsFDA 0 Votes 1 Ans Revalidation of computerized systems. What is required for computerized materials management systems used to monitor receipts, sampling testing or release of materials? 1.53K viewsFDA « Previous 1 2 … 72 73 74 75 76 Next » Question and answer is powered by anspress.net
