FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is the CFR legally binding? 1.45K viewsFDA 0 Votes 1 Ans What is the main difference between Annex 11 and 21 CFR Part 11? 1.65K viewsFDA 0 Votes 1 Ans What is FDA regulations? 1.71K viewsFDA 0 Votes 1 Ans What is the difference between ISO 13485 and 21 CFR 820? 1.56K viewsFDA 0 Votes 1 Ans What 21cfr 820? 1.45K viewsFDA 0 Votes 1 Ans What is CFR 21 compliance? 1.65K viewsFDA 0 Votes 1 Ans What does Title 21 of CFR describe? 1.57K viewsFDA 0 Votes 1 Ans What is 21 CFR Part 820 and why should you care? 1.49K viewsFDA 0 Votes 1 Ans Should an Excel spreadsheet be validated that is used for trending of stability data? 1.59K viewsFDA 0 Votes 1 Ans Auditing Systems for 21 CFR Part 11- Validation and Qualification – What are differences between Validation and Qualification? 1.40K viewsFDA 0 Votes 1 Ans Auditing Systems for 21 CFR Part 11 -Validation- How do we keep our validations from becoming “War and Peace” (very large)? 1.59K viewsFDA 0 Votes 1 Ans In process validation, how important is VMP? 1.62K viewsFDA 0 Votes 1 Ans what is root cause analysis? 1.72K viewsFDA 0 Votes 1 Ans Is Haccp mandatory? 1.32K viewsFDAFood Safety 0 Votes 1 Ans Will a laboratory subsequently be notified of GLP deviations not listed on the FDA-483? 1.44K viewsFDA 0 Votes 1 Ans What amount of detail should be included in the standard operating procedures (SOPs)? 1.40K viewsFDA 0 Votes 1 Ans To what extent are computer programs to be documented as SOPS? 1.44K 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? 1.41K 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? 1.70K viewsFDA 0 Votes 1 Ans When making corrections to documented entries, the only requirements are to sign, date, and leave original entry readable. Was there any discussion when writing Q7A to also record the reason for the change? Will field investigators expect this? 1.67K viewsFDA « Previous 1 2 3 4 5 … 75 76 Next » Question and answer is powered by anspress.net
