Building a Clinical Trial Site Quality Management System - Webinar CD/Transcript

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Building a Clinical Trial Site Quality Management System

There's only one way to run your clinical trials in full compliance with Good Clinical Practices (GCPs) and satisfy both the FDA and sponsors.

By putting a comprehensive, effective and functioning Quality Management System (QMS) in place.

But what does a first class QMS look like? What elements must it have? And how does it actually work?

Find out by ordering the Building a Clinical Trial Site Quality Management System webinar CD and transcript. FDAnews is pleased to present Dr. Susan Leister, an 18-year industry veteran who has helped countless sites implement, audit and improve their quality management systems.

This is an excellent opportunity to learn what it takes to establish a first-class quality management system NOW and avoid the unpleasant surprise LATER of learning your clinical trial site needs one because you've been found out of compliance by an FDA inspector.

In 90 minutes, Dr. Leister will take you beyond the regulations, showing real-life examples of how to create a quality management system that works — not just on paper, but in practice.

Dr. Lester will discuss the key concepts and practices that make up an effective quality management system, including the following:

  • Document Control processes and the use of Standard Operating Procedures (SOPs)
  • Best practices for an all-inclusive training program
  • Best practices for a comprehensive audit program (internal and external)
  • Root cause analysis tools and typical pitfalls when investigating problems
  • A proactive approach to CAPAs (Corrective and Preventive Actions)

Whether your site is new to establishing a quality management system, or has a system in place that you want to ensure is compliant, this webinar CD and transcript is for you.

  • Regulatory affairs directors
  • Compliance officers
  • Legal counsel
  • Clinical quality directors

Dr. Susan Leister serves as the Director of Quality Assurance at Technical Resources International with over 18 years of industry experience. In addition, She has also been a part-time faculty member of the University of Phoenix Undergraduate and Graduate School of Business for the last five years.

She holds certifications from ASQ as a CQA and a CSSBB. She serves on the ASQ Section 509 Executive Committee and served as a 2012 and 2013 Maryland Performance Excellence Award Examiner and a 2013 ASQ International Team Excellence Award Judge.