2008年12月5日 · 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 pharmaceutical industry, this is a controlled process so that the number of labels printed equals the number of bottles being filled.

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 the drug that is both serious and unexpected • Reporting responsibilities – Sponsor reports to FDA and investigators – Investigators report to ...

2022年12月31日 · 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 timely manner, appropriately identify root causes, expand investigations to …

2008年9月17日 · 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 there are other clauses to give a flavour of the requirements: 4 Justification for a clinical investigation 5 - Ethical consideratios 5.1 - Declaration of Helsinki

2023年4月17日 · -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 comng from different type of samples and different types of NGS? (e.g., verify that the SW performs well with liquid and solid tumour samples, WES, gene panels, etc?)

2024年10月21日 · 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 of the area showed a value within the established range. Both readings were reported with the investigation attached to show the reason for the re-sampling.

2024年11月13日 · 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 specific action request (how we track scrap and customer returns) in his NCR on Oasis, however that is not the Action...

2018年2月6日 · 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 (regarding to the recommendation of the Meddev 2.7/1 révision 4 and new EU regulation) : - a clinical investigation...

2013年4月22日 · The second choice from the top at the DRLM Main Menu page allows you to see your facility information (which I understand is not changing), your owner/operator information (which I understand you want to change), and your official correspondent information.

2017年3月20日 · investigation is conducted. Uncontrolled destruction of CGMP records also raises concerns, because retention of CGMP records must follow established procedures approved by your quality unit. (January 2017)