FDAnews Announces — Building a Clinical Trial Site Quality Management System Webinar, July 14, 2015

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There's only one way to run clinical trials in full compliance with Good Clinical Practices (GCPs) and satisfy both the FDA and sponsors. Find out by registering for the webinar Building a Clinical Trial Site Quality Management System on Tuesday, June 14, 2015 at 11 a.m. EDT, led by Dr. Susan Leister, an industry veteran who has helped countless sites implement, audit and improve their quality management systems.

Building a Clinical Trial Site Quality Management System
**FDAnews Webinar**
July 14, 2015 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/ctsitemanagement

There's only one way to run 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 registering for the webinar Building a Clinical Trial Site Quality Management System on Tuesday, June 14, 2015 at 11 a.m. EST. 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 that the clinical trial site needs one because it’s been found out of compliance by an FDA inspector.

In 90 minutes, Dr. Leister will take attendees 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)

Meet the Presenter:
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.

Who Will Benefit:

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

Webinar Details:
Building a Clinical Trial Site Quality Management System
**FDAnews Webinar**
July 14, 2015 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/ctsitemanagement

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/ctsitemanagement
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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