Training Course Syllabus:
Clinical Trial Site Quality Management System Webinar
Time: 11:30 AM PDT, 02:30 PM EDT
Duration: 120 Minutes
This session will cover the essential requirements of a clinical site Quality Management System (QMS). We will discuss the necessary elements to include in your system such as a document management program, a training program, and an audit program. In addition, we will discuss how to ensure your CAPA (Corrective and Preventative Action) program is effective, and root cause analysis process is working. These processes are essential to ensuring problem resolution is properly functioning and process improvement is effective. Pitfalls and best practices will be discussed to help you enhance your QMS.
Why Should you Attend:
Attending this session will help one gain additional quality skills and tools which can improve your overall site performance. This session will help a clinical site build a stronger Quality Management System by eliminating potential weaknesses within their quality programs. Having a well-organized and effective QMS helps the site be inspection ready for the various regulatory audits that may come their way. This webinar reviews the critical elements of the QMS and discuss challenges, best practices, and things to consider to help clinical staff develop or improve their system.
Objectives of the Presentation:
- Discuss the key components of a QMS
- Discuss the key elements of a document management program
- Discuss the critical aspects of a training program
- Discuss the key elements of an audit program
- Discuss the key components of a CAPA program
- Discuss the critical aspects of root cause analysis