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  • Creating a Quality Assurance Program for (Clinical) Research

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Wednesday - May 15, 2013 10:00 AM
  • End Time:
  • Wednesday - May 15, 2013 11:00 AM
  • Location:
  • Online
  • This clinical research QA training will provide practical advice for clinical research sites on when and how to get started with building their quality assurance program. A table of contents of the most critical SOPs will be provided.

    This one-hour webinar training will provide practical guidance on a GCP quality system for clinical research sites. This session will review the GCP regulations, ICH guidelines, key roles and responsibilities, and provide an outline to get started on a quality system build. Tips on the development and roll-out of the quality assurance program across the site will also be discussed.

    Why Should You Attend:

    - Does your site lack any documented quality assurance processes? Or, do you have a quality system and SOPs that are hard to use and not reflective of your processes?
    - Have you received some recent 483's after an FDA inspection?
    - Are you a new CRC, research director, or PI that is building the research practice and would like to learn more about the role of a quality assurance system for your site?
    - Are you looking for some additional training for your staff?
    - Are you a sponsor or CRO who has responsibility for oversight and training of site personnel?
    - Do you conduct site assessment and audits? Do you conduct study monitoring?

    If yes, you should consider attending this one-hour webinar.

    Learning Objective:

    At the end of this webinar, participants will better understand the GCP regulations, the need for a quality assurance program for a research site, and how they can get started building the system that day.
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