FDAnews Announces — Think Like a Clinical Trial Site Auditor: Strategies for Successful Monitoring Webinar, July 29, 2015

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Clinical trial site monitors are expected to ensure a study site is following study protocol and GCPs — and, when necessary, identify and fix deficiencies. Attendees of the July 29 FDAnews webinar Think Like a Clinical Trial Site Auditor: Strategies for Successful Monitoring will learn to start thinking from the perspective of an auditor, rather than waiting fearfully for what an auditor might have to say about the site.

FDAnews

FDAnews

Think Like a Clinical Trial Site Auditor:
Strategies for Successful Monitoring
**FDAnews Webinar**
July 29, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ctsiteauditor

Clinical trial site monitors are expected to ensure a study site is following study protocol and GCPs — and, when necessary, identify and fix deficiencies.

Studies show, however, that monitors that are good at identifying deficiencies frequently fail when it comes to fixing them.
What does this mean? That a site may have serious deficiencies (or worse, a pattern of serious deficiencies) that could require lengthy and expensive CAPAs … extensive remediation … and even lost trial data.

How can trial sites avoid getting into such situations?

By attending the July 29 FDAnews webinar Think Like a Clinical Trial Site Auditor: Strategies for Successful Monitoring.

In this session, attendees will learn to start thinking from the perspective of an auditor, rather than waiting fearfully for what an auditor might have to say about a site.

In doing so, attendees will quickly find their monitoring practices transformed, becoming far more effective than in the past, going beyond spotting problems to actually fixing them.

In just 90 minutes, attendees will learn such specifics as:

  •     Key differences between auditing and monitoring and how to look at a site more like an auditor does
  •     Strategies used by seasoned auditors to help them move beyond simply listing deficiencies and focus on the correct issues
  •     Going beyond the template. A site monitoring template is a great roadmap for finding and fixing problems at a site
  •     Practical methods to eliminate finger-pointing and, instead, launch effective corrective and preventive actions in response to monitoring findings

Plus, attendees will gain understanding of how to prepare monitoring reports with an auditor's thought process in mind … the problem patterns auditors watch for in reports … how auditors suss out deficiencies over time, by investigator, even by checking office records … and much more.

Finally, attendees will learn how monitors, study coordinators and investigators can all work together to successfully find the root of a problem, rather than just document deficiencies.

Meet the Presenter:
Ms. Pamela Nelson, RN, currently resides in Allen, TX. Pam has been a nurse for over 30 years. She worked for many years in Oncology before entering into Clinical Research.
Pam founded the Bracane Company, a medical services consulting firm in 2002. The Bracane Company provides functional services to the research industry including trial management, supplies and QA compliance. The Bracane Company is a Certified Minority Woman Owned Business Enterprise.

Who Will Benefit:

  •     Regulatory affairs directors
  •     Compliance officers
  •     Legal counsel

Conference Details:
Think Like a Clinical Trial Site Auditor:
Strategies for Successful Monitoring
**FDAnews Webinar**
July 29, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ctsiteauditor

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/ctsiteauditor
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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