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.

Description

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. 

Areas Covered

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


Speaker Profile

Richard Chamberlain

Richard Chamberlain has a Ph.D. in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, Data Management, computerized project scheduling, strategic planning, and Quality Management.

He has assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and Compliance to Regulations.

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