Webinar: The updated BIMO guide’s expectations related to Sponsor Organization’s Quality Management Systems

Wednesday, March 9, 2022  |  1:30pm – 2:30pm EST

Quality Management Systems (QMS) has been called out as a regulatory expectation in ICH E6 R2 and the ICH E6 R3 business plan indicates that this is a key component of high-quality clinical trial execution. The recent BIMO guide that was released also indicates that inspectors will be further scrutinizing an organization’s policies, procedures, risk management and will focus on whether or not the Sponsors are showing continuous improvement of their quality management system. The Avoca Quality Consortium 12 component quality management framework is a guideline for Sponsors to evaluate their QMS and determine areas of weakness as it relates to regulatory and compliance as well as industry-leading practice. Ensuring a quality management system is in place prior to conducting clinical trial activities that are likely to be inspected by regulatory agencies yields more successful inspection results.

In this webinar, you’ll learn:

• The importance of a Quality Management System in ensuring inspection readiness per new BIMO guidelines
• How an organization’s quality culture impacts the success of the holistic Quality Management System
• The twelve key components of a holistic Quality Management System
• How to ensure continuous improvement in your Quality Management System