FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What are the factors that determine whether the FDA will conduct a pre-announced or an unannounced inspection? 1.04K viewsFDA 0 Votes 1 Ans Do all pharmaceutical companies get inspected at some point? 1.02K viewsFDA 0 Votes 1 Ans What are the top three things that an FDA investigator looks for during a GMP inspection and why? 1.21K viewsFDA 0 Votes 1 Ans What are some of the most common reasons why companies get a Form FDA-483? 1.19K viewsFDA 0 Votes 1 Ans What are the things that FDA investigators look for in terms of training, training control, and training documentation? 1.25K viewsFDA 0 Votes 1 Ans How do you evaluate training? How can you tell if a company is in compliance with training requirements? 897 viewsFDA 0 Votes 1 Ans How do you evaluate training? How can you tell if a company is in compliance with training requirements? 1.10K viewsFDA 0 Votes 1 Ans What are the things that FDA investigators look for in terms of a company’s CAPA process? 1.05K viewsFDA 0 Votes 1 Ans What’s your advice to companies that are preparing for an FDA inspection — let’s say, a post-approval (CGMP) inspection? 1.29K viewsFDA 0 Votes 1 Ans What does FDA consider to be raw data? 1.16K viewsFDA 0 Votes 1 Ans What is the FDA’s objective when conducting a Sponsor/Monitor inspection? 1.19K viewsFDA 0 Votes 1 Ans How does FDA expect sponsors to handle protocol deviations and non-compliance issues at clinical sites? 1.17K viewsFDA 0 Votes 1 Ans Is the FDA focusing on computerized systems more during Sponsor/Monitor inspections? 1.16K viewsFDA 0 Votes 1 Ans What documents from the many available on the FDA web site are most helpful in understanding and preparing for FDA GCP inspections? 1.27K viewsFDA 0 Votes 1 Ans How does FDA define data integrity? 937 viewsFDA 0 Votes 1 Ans What is metadata? 958 viewsFDA 0 Votes 1 Ans What is an audit trail? 1.22K viewsFDA 0 Votes 1 Ans Can electronic copies be used as accurate reproductions of paper or electronic records? 1.12K viewsFDA 0 Votes 1 Ans Does each workflow on the organization’s computer need to be validated? 1.14K viewsFDA 0 Votes 1 Ans How should access to CGMP computer systems be restricted? 1.22K viewsFDA « Previous 1 2 … 47 48 49 50 51 … 75 76 Next » Question and answer is powered by anspress.net
