Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What are the Serialization Requirements? 1.72K viewsMedical Device 0 Votes 1 Ans What is Mission-Critical Compliance Strategies? 1.63K viewsMedical Device 0 Votes 1 Ans What are the Integrating Systems to Streamline Serialization? 1.51K viewsMedical Device 0 Votes 1 Ans What are the Business Benefits of Serialization? 1.67K viewsMedical Device 0 Votes 1 Ans How to Reduce Recalls with Proactive Risk Management? 1.55K viewsMedical Device 0 Votes 1 Ans What does the recall management process consists of? 1.55K viewsMedical Device 0 Votes 1 Ans What are Some benefits to using risk management for reducing chance of recall ? 1.54K viewsMedical Device 0 Votes 1 Ans What is ISO? 1.54K viewsMedical Device 0 Votes 1 Ans What are the benefits of ISO certification? 1.63K viewsMedical Device 0 Votes 1 Ans How does a company get ISO certification? 1.68K viewsMedical Device 0 Votes 1 Ans If class I in Europe device can it be used in US FDA study? What about outside labeling? 1.49K viewsMedical Device 0 Votes 1 Ans Is it acceptable to use a third party lab’s available pharmacopeial reference standard to qualify an establishment’s secondary standard? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Inspectorate’s position on the use of loose work sheets as opposed to bound notebooks for the purpose of recording laboratory data? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans It is generally accepted in the industry to perform process validation on three consecutive lots. How does the Inspectorate view validation when reworking is required (i.e., three consecutive incidents will never happen)? 987 viewsDrugsPharmaceutical 0 Votes 1 Ans Is it mandatory for the approval of a procedure to sign each page or is it acceptable to only sign the first page? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Inspectorate’s position on 2-mercaptobenzothiazole (MBT) in rubber closures? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to include a chemical identification test in a specification for a packaging component (such as a plastic bottle)? Must this chemical identification (ID) be conducted for each lot received? Would vendor certification be considered an acceptable substitution for testing upon receipt? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans Can industrial grade nitrogen be used as a blanketing agent during the manufacture of a drug product? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Do bacteriostasis and fungistasis testing have to be performed for each lot of product in reference to the United States Pharmacopoeia (USP) sterility test? 827 viewsDrugsPharmaceutical 0 Votes 1 Ans What are the latest The Latest Developments in Medical Devices? 1.56K viewsMedical Device « Previous 1 2 … 193 194 195 196 197 … 283 284 Next » Question and answer is powered by anspress.net
