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 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?)

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 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 ...

Dec 2, 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 timely manner, appropriately identify root causes, expand investigations to …

Dec 19, 2024 · Hi all It is very common that medical device companies are documenting and tracing design requirements and V&V in a matrix format for traceability, but to my impression is not that common to do it when it comes to equipment URS requirements FAT/SAT and process validation testing. Has any of you...

Dec 18, 2013 · Re: Bench Test definition (in FDA context) and its difference with Clinical Study? I tend to agree with Yodon. If you refer to ISO 14155-1:2003 " Clinical investigation of medical devices for human subjects - Part 1: General Requirements" you will get an idea how much is involved and the controls required in a device clinical investigation (i.e. study

May 19, 2011 · To give you some idea, oxygen compressed gas cylinders are labeled either with USP (drug gases) or non USP grade (medical device gases: e.g aerobic, lung diffusion, biological atm). The bulk O2 for packaging these gases are also from 2 sources, one USP grade other is industrial high purity grade.

Jul 14, 2020 · What is the general thinking about the requirement of usability testing prior to the submission of an FDA IDE? Is FDA requiring it? It seems to me that we should be able to justify using pre-clinical data that the clinical trial will be used to support usability, as long as usability is...

Jan 24, 2013 · In Sterility Testing, the intent is to find if the batch is sterile / non sterile and only 2 liquid media - Trytic Soy Broth (for aerobic organisms) and Fluid Thioglycollate Broth (for anaerobic organisms) are employed and any growth in the media indicates that the batch could be contaminated and requiring further investigation.

Feb 22, 2013 · Following the storage, the unit failed the test protocol. Upon investigation, it was clear that electronic and mechanical components, interior and exterior on the UUT, sustained corrosion due to condensation during the storage period. IMHO, this test failed to meet the "non-condensing" conditions of the test.