Live Webinar Quality Assurance During the Clinical Trial
12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 90 Minute
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
"Hear By Richard Chamberlain has a Ph.D. in Statistics and Owner at Extended Clinical Services, LLC"
This course will give you an introduction to where to do quality assurance and how to do it.
Quality and Quality Assurance are very important to virtually all aspects of Clinical Research. The FDA requires certain Quality Assurance practices to know things are being done to the best quality. Clinical trials form the basis for much of the research done for new drug approval. While the study is being conducted QA procedures must be applied to assure good quality results.
Why should you attend
This course will give you an introduction to where to do quality assurance and how to do it. There will be an introduction the various areas that should be audited as well as what is contained in an audit report.
Another aspect covered is how to follow-up on the results of an audit.
The course will cover the areas or topics that typically need to be monitored during the three parts of a clinical trial – Study Start-up, Study Execution, and Study Close-out. This will include things done by the Sponsor, The Site seeing the patients, and sites that are supporting the study, such as laboratories.
Who will Benefit
Those at the sponsor that are responsible for the conduct of the study.
The medical staff that see the patients during the trial.
Those working in a laboratory that is processing samples
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel