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 in the Session
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.
Richard L. Chamberlain,
Richard Chamberlain's experience includes consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation. He has also managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.
Apart from these Mr Chamberlain has taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems; assisted in the development and validation of numerous computerized systems in all GxP environments; assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and Compliance to Regulations. He is also familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs.