drug experience associated with the use of the drug in clinical studies that was fatal or life- threatening – 15 Day IND Safety Reports: Any adverse experience associated with the use of …

Jan 1, 2022 · we have had an interesting discussion about the purpose of the deviation section and handling of the events noted during the method validation analysis The contents of the …

Dec 5, 2008 · If you are filling bottles with drug substance, then you need to consider the following when you conduct your investigation: 1. The process of printing the labels - In the …

Apr 17, 2023 · -what it is expected for the analytical perforance (AP)? -->should we demonstrate via a clinical investigation or via software verification tests that the SW can analyze NGS data …

May 15, 2013 · Fortune's investigation yields the first comprehensive picture of how one under-policed and far-flung generics company operated. It is not a tale of cutting corners or lax …

Oct 21, 2024 · After investigating, it turns out an employee was cleaning a production area at the time and sprayed a cleaning solution which affected the particle count reading. A re-sampling …

Dec 31, 2022 · DuPont Nutrition USA Inc. - 627211 - 12/02/2022 1. Your firm failed to perform adequate investigation of complaints. 2. You failed to thoroughly investigate OOS results in a …

Sep 17, 2008 · Clause 3.4 clinical investigation - any designed and planned systematic study in human subjects undertaken to verify the safety and/or performance of a specific device). Then …

Nov 13, 2024 · During our recent AS9100 Audit, we had a minor NCR against 10.2.1, that the process for determining the causes of nonconfomities is not fully effective. The Auditor sited a …

Feb 6, 2018 · Hi I'm a trainee in regulatiuon and quality management system. I'm asked to do the clinical evaluation for a medical device Does any one have an exemple or template of …