Quality Management of Electronic Systems in Clinical Trial Investigations: A detailed analysis and risk management techniques for FDA and EMA Guidance

Vidia Ramdeen

Starting at

$249


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As clinical researchers, we are challenged to fully integrate the management systems needed across functional areas within our electronic systems. Most frequently, the IT group and vendor manage the technology, but software AND process needs to be managed and understood by other cross-functional areas when conducting day to day trial activities to support human subject protection and data integrity. This includes pre-study protocol development, vendor and site selection activities, subject safety surveillance, data management, site monitoring, protocol management, project management, and more. 

This webinar presents an overview of the quality management of electronic systems in clinical trials for cross-functional teams. The session includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials. 

LEARNING OBJECTIVES

By attending this interactive session, you will be able to…

  • Identify specific quality systems elements to support the use of electronic systems regarding sponsor, site, and IRB/EC regulatory responsibilities
  • Avoid the most common misconceptions related to use of electronic records
  • Recognize the process of ensuring the use of electronic records supports the predicate rules for sponsors, investigators, and IRBs/ECs

Who Sould Attend:

This course will be of benefit to anyone working in a GCP regulated or clinical trial environment on global or domestic scale who manages clinical quality management systems (CQMS) at a sponsor, CRO, or site level. This includes personnel in…

  • Quality
  • Clinical Operations
  • Clinical Monitoring
  • Other related functions
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Vidia Ramdeen,

Vidia Ramdeen MPA SSBB is a research consultant with experience across a broad array of industries including health care, medical, biomedical, and biotechnology. In addition, his research experience includes strategy, innovation, leadership, solutions-based, and management consulting. His knowledge of compliance issues is a function of consulting responsibilities that provide a fundamental base to analyze today’s complex compliance environment.




Get in touch

(315) 632-0735,
(315) 750-4379